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Clinical psychoeconomics: Accounting for money matters in psychiatric assessment and treatment
Despite money’s central role in our psychic lives, many trainees – and some seasoned practitioners – skirt around financial issues. Some clinicians confess that inquiring about patients’ finances feels “too personal.” They fear that asking about money could suggest that the clinician is primarily concerned with getting paid. Some clinicians feel that looking into patients’ finances might be unprofessional, outside one’s scope of practice. But it is not.
Trainees often receive little guidance concerning money matters in patients’ lives and treatments, considerations we have labeled clinical psychoeconomics. Considerable evidence suggests that financial concerns often provoke emotional distress and dysfunctional behaviors, and directly influence patient’s health care decisions. Financial issues also influence how clinicians view and react to patients.
We have recently reviewed (and illustrated through case vignettes) how money matters might impact psychiatric assessment, case formulation, treatment planning, and ongoing psychiatric treatments including psychotherapies.1 Consider how money affects people’s lives: Money helps people meet multiple practical, psychological, and social needs by enabling them to obtain food, clothing, shelter, other material goods, services, discretionary time, and opportunities. And money strongly influences relationships. Regardless of poverty or wealth, thoughts and behaviors connected to acquiring, possessing, and disposing of money, and feelings accompanying these processes such as greed, neediness, envy, pride, shame, guilt, and self-satisfaction often underly intrapsychic and interpersonal conflicts.
Individuals constantly engage in numerous simultaneous conscious, preconscious, and unconscious neuro-economic trade-offs that determine goals, efforts, and timing. Many are financially influenced. Money influences how virtually all patients seek, receive, and sustain their mental health care including psychotherapy.
Money problems can be associated with insecurity, impotence, feeling unloved, and lack of freedom or subjugation. Individuals may resent how they’re forced to acquire money, and feel shamed or morally injured by their jobs, financial dependence on other family members, public assistance, or their questionable ways of obtaining money.
Impoverished individuals may face choosing between food, housing, medications, and medical care. Domestically abused individuals may reluctantly remain with their abusers, risking physical harm or death rather than face destitution. Some families tolerate severely disabled individuals at home because they rely on their disability checks and caregiver payments. Suicides may turn on how individuals forecast financial repercussions affecting their families. Desires to avoid debt may lead to treatment avoidance.
Individuals with enough money to get by face daily financially related choices involving competing needs, desires, values, and loyalties. They may experience conflicts concerning spending on necessities vs. indulgences or spending on oneself vs. significant others.
Whereas some wealthy individuals may assume unwarranted airs of superiority and entitlement, others may feel guilty about wealth, or fearful that others like them only for their money. Individuals on the receiving end of wealth may feel emotionally and behaviorally manipulated by their benefactors.
Assessment
Assessments should consider how financial matters have shaped patients’ early psychological development as well their current lives. How do patients’ emotions, thoughts, and behaviors reflect money matters? What money-related pathologies are evident? What aspects of the patient’s “financial world” seem modifiable?
Financial questions should be posed colloquially. Screeners include: “Where do you live?”, “Who’s in the home?”, “How do you (all) manage financially?”, “What do you all do for a living?”, “How do you make ends meet?”, and “What financial problems are you facing?” Clinicians can quickly learn about patients’ financial self-sufficiencies, individuals for whom they bear financial responsibility, and others they rely on for support, for example, relatives. If patients avoid answering such questions forthrightly, particularly when financial arrangements are “complicated,” clinicians will want to revisit these issues later after establishing a firmer alliance but continue to wonder about the meaning of the patient’s reluctance.
When explicit, patients, families, and couples are fully aware of the conflicts but have difficulty resolving financial disputes. When conflicts are implicit, money problems may be unacknowledged, avoided, denied, or minimized. Conflicts concerning money are often transmitted trans-generationally.
Psychopathological conditions unequivocally linked to money include compulsive shopping, gambling disorders, miserly hoarding, impulse buying, and spending sprees during hypomanic and manic states. Mounting debts may create progressively insurmountable sources of distress. Money can be weaponized to sadistically create enticement, envy, or deprivation. Some monetarily antisocial individuals compromise interpersonal relationships as well as treatments. Individuals with alcohol/substance use disorders may spend so much on substances that little is left for necessities. Financially needy individuals may engage in morally questionable behaviors they might otherwise shun.
Case formulation and treatment planning
Incorporating money matters into case formulations entails demonstrating how financial concerns influenced maladaptive development and distort current attitudes, perceptions, and behaviors.
Concurrently, clinicians should acknowledge patients’ reality-based fiscal decisions, appreciating cultural and family value differences concerning how money should be acquired and spent. Since money often determines frequency and duration of treatment visits, clinicians are ethically obligated to discuss with patients what they might expect from different medications and psychotherapies, and their comparative costs.
Money matters’ impact on psychotherapies
Money matters often affect transference and countertransference reactions. Some reactions stem from how patients and clinicians compare their own financial situations with those of the other.
To help identify and ameliorate money-related countertransference responses, clinicians can reflect on questions such as: “How comfortable are you with people who are much poorer or richer than you are?” “How comfortable are you with impoverished individuals or with multimillionaires or their children?” And “why?” For trainees, all these reactions should be discussed in supervision.
Conclusions
To summarize, four clinical psychoeconomic issues should be routinely assessed and factored into psychiatric case formulations and treatment plans: how financial issues 1) have impacted patients’ psychological development; 2) impact patients’ current lives; 3) are likely to impact access, type, intensity, and duration of treatment visits; and 4) might provoke money-related transference and countertransference concerns.
In advising patients about treatment options, clinicians should discuss each treatment’s relative effectiveness and estimated costs of care. Patients’ decisions will likely be heavily influenced by financial considerations.
Dr. Yager is based in the department of psychiatry, University of Colorado at Denver, Aurora. Dr. Kay is based in the department of psychiatry, Wright State University, Dayton, Ohio. No external funds were received for this project, and the authors have no conflicts to disclose.
Reference
1. Yager J and Kay J. Money matters in psychiatric assessment, case formulation, treatment planning, and ongoing psychotherapy: Clinical psychoeconomics. J Nerv Ment Dis. 2022 Jun 10. doi: 10.1097/NMD.0000000000001552.
Despite money’s central role in our psychic lives, many trainees – and some seasoned practitioners – skirt around financial issues. Some clinicians confess that inquiring about patients’ finances feels “too personal.” They fear that asking about money could suggest that the clinician is primarily concerned with getting paid. Some clinicians feel that looking into patients’ finances might be unprofessional, outside one’s scope of practice. But it is not.
Trainees often receive little guidance concerning money matters in patients’ lives and treatments, considerations we have labeled clinical psychoeconomics. Considerable evidence suggests that financial concerns often provoke emotional distress and dysfunctional behaviors, and directly influence patient’s health care decisions. Financial issues also influence how clinicians view and react to patients.
We have recently reviewed (and illustrated through case vignettes) how money matters might impact psychiatric assessment, case formulation, treatment planning, and ongoing psychiatric treatments including psychotherapies.1 Consider how money affects people’s lives: Money helps people meet multiple practical, psychological, and social needs by enabling them to obtain food, clothing, shelter, other material goods, services, discretionary time, and opportunities. And money strongly influences relationships. Regardless of poverty or wealth, thoughts and behaviors connected to acquiring, possessing, and disposing of money, and feelings accompanying these processes such as greed, neediness, envy, pride, shame, guilt, and self-satisfaction often underly intrapsychic and interpersonal conflicts.
Individuals constantly engage in numerous simultaneous conscious, preconscious, and unconscious neuro-economic trade-offs that determine goals, efforts, and timing. Many are financially influenced. Money influences how virtually all patients seek, receive, and sustain their mental health care including psychotherapy.
Money problems can be associated with insecurity, impotence, feeling unloved, and lack of freedom or subjugation. Individuals may resent how they’re forced to acquire money, and feel shamed or morally injured by their jobs, financial dependence on other family members, public assistance, or their questionable ways of obtaining money.
Impoverished individuals may face choosing between food, housing, medications, and medical care. Domestically abused individuals may reluctantly remain with their abusers, risking physical harm or death rather than face destitution. Some families tolerate severely disabled individuals at home because they rely on their disability checks and caregiver payments. Suicides may turn on how individuals forecast financial repercussions affecting their families. Desires to avoid debt may lead to treatment avoidance.
Individuals with enough money to get by face daily financially related choices involving competing needs, desires, values, and loyalties. They may experience conflicts concerning spending on necessities vs. indulgences or spending on oneself vs. significant others.
Whereas some wealthy individuals may assume unwarranted airs of superiority and entitlement, others may feel guilty about wealth, or fearful that others like them only for their money. Individuals on the receiving end of wealth may feel emotionally and behaviorally manipulated by their benefactors.
Assessment
Assessments should consider how financial matters have shaped patients’ early psychological development as well their current lives. How do patients’ emotions, thoughts, and behaviors reflect money matters? What money-related pathologies are evident? What aspects of the patient’s “financial world” seem modifiable?
Financial questions should be posed colloquially. Screeners include: “Where do you live?”, “Who’s in the home?”, “How do you (all) manage financially?”, “What do you all do for a living?”, “How do you make ends meet?”, and “What financial problems are you facing?” Clinicians can quickly learn about patients’ financial self-sufficiencies, individuals for whom they bear financial responsibility, and others they rely on for support, for example, relatives. If patients avoid answering such questions forthrightly, particularly when financial arrangements are “complicated,” clinicians will want to revisit these issues later after establishing a firmer alliance but continue to wonder about the meaning of the patient’s reluctance.
When explicit, patients, families, and couples are fully aware of the conflicts but have difficulty resolving financial disputes. When conflicts are implicit, money problems may be unacknowledged, avoided, denied, or minimized. Conflicts concerning money are often transmitted trans-generationally.
Psychopathological conditions unequivocally linked to money include compulsive shopping, gambling disorders, miserly hoarding, impulse buying, and spending sprees during hypomanic and manic states. Mounting debts may create progressively insurmountable sources of distress. Money can be weaponized to sadistically create enticement, envy, or deprivation. Some monetarily antisocial individuals compromise interpersonal relationships as well as treatments. Individuals with alcohol/substance use disorders may spend so much on substances that little is left for necessities. Financially needy individuals may engage in morally questionable behaviors they might otherwise shun.
Case formulation and treatment planning
Incorporating money matters into case formulations entails demonstrating how financial concerns influenced maladaptive development and distort current attitudes, perceptions, and behaviors.
Concurrently, clinicians should acknowledge patients’ reality-based fiscal decisions, appreciating cultural and family value differences concerning how money should be acquired and spent. Since money often determines frequency and duration of treatment visits, clinicians are ethically obligated to discuss with patients what they might expect from different medications and psychotherapies, and their comparative costs.
Money matters’ impact on psychotherapies
Money matters often affect transference and countertransference reactions. Some reactions stem from how patients and clinicians compare their own financial situations with those of the other.
To help identify and ameliorate money-related countertransference responses, clinicians can reflect on questions such as: “How comfortable are you with people who are much poorer or richer than you are?” “How comfortable are you with impoverished individuals or with multimillionaires or their children?” And “why?” For trainees, all these reactions should be discussed in supervision.
Conclusions
To summarize, four clinical psychoeconomic issues should be routinely assessed and factored into psychiatric case formulations and treatment plans: how financial issues 1) have impacted patients’ psychological development; 2) impact patients’ current lives; 3) are likely to impact access, type, intensity, and duration of treatment visits; and 4) might provoke money-related transference and countertransference concerns.
In advising patients about treatment options, clinicians should discuss each treatment’s relative effectiveness and estimated costs of care. Patients’ decisions will likely be heavily influenced by financial considerations.
Dr. Yager is based in the department of psychiatry, University of Colorado at Denver, Aurora. Dr. Kay is based in the department of psychiatry, Wright State University, Dayton, Ohio. No external funds were received for this project, and the authors have no conflicts to disclose.
Reference
1. Yager J and Kay J. Money matters in psychiatric assessment, case formulation, treatment planning, and ongoing psychotherapy: Clinical psychoeconomics. J Nerv Ment Dis. 2022 Jun 10. doi: 10.1097/NMD.0000000000001552.
Despite money’s central role in our psychic lives, many trainees – and some seasoned practitioners – skirt around financial issues. Some clinicians confess that inquiring about patients’ finances feels “too personal.” They fear that asking about money could suggest that the clinician is primarily concerned with getting paid. Some clinicians feel that looking into patients’ finances might be unprofessional, outside one’s scope of practice. But it is not.
Trainees often receive little guidance concerning money matters in patients’ lives and treatments, considerations we have labeled clinical psychoeconomics. Considerable evidence suggests that financial concerns often provoke emotional distress and dysfunctional behaviors, and directly influence patient’s health care decisions. Financial issues also influence how clinicians view and react to patients.
We have recently reviewed (and illustrated through case vignettes) how money matters might impact psychiatric assessment, case formulation, treatment planning, and ongoing psychiatric treatments including psychotherapies.1 Consider how money affects people’s lives: Money helps people meet multiple practical, psychological, and social needs by enabling them to obtain food, clothing, shelter, other material goods, services, discretionary time, and opportunities. And money strongly influences relationships. Regardless of poverty or wealth, thoughts and behaviors connected to acquiring, possessing, and disposing of money, and feelings accompanying these processes such as greed, neediness, envy, pride, shame, guilt, and self-satisfaction often underly intrapsychic and interpersonal conflicts.
Individuals constantly engage in numerous simultaneous conscious, preconscious, and unconscious neuro-economic trade-offs that determine goals, efforts, and timing. Many are financially influenced. Money influences how virtually all patients seek, receive, and sustain their mental health care including psychotherapy.
Money problems can be associated with insecurity, impotence, feeling unloved, and lack of freedom or subjugation. Individuals may resent how they’re forced to acquire money, and feel shamed or morally injured by their jobs, financial dependence on other family members, public assistance, or their questionable ways of obtaining money.
Impoverished individuals may face choosing between food, housing, medications, and medical care. Domestically abused individuals may reluctantly remain with their abusers, risking physical harm or death rather than face destitution. Some families tolerate severely disabled individuals at home because they rely on their disability checks and caregiver payments. Suicides may turn on how individuals forecast financial repercussions affecting their families. Desires to avoid debt may lead to treatment avoidance.
Individuals with enough money to get by face daily financially related choices involving competing needs, desires, values, and loyalties. They may experience conflicts concerning spending on necessities vs. indulgences or spending on oneself vs. significant others.
Whereas some wealthy individuals may assume unwarranted airs of superiority and entitlement, others may feel guilty about wealth, or fearful that others like them only for their money. Individuals on the receiving end of wealth may feel emotionally and behaviorally manipulated by their benefactors.
Assessment
Assessments should consider how financial matters have shaped patients’ early psychological development as well their current lives. How do patients’ emotions, thoughts, and behaviors reflect money matters? What money-related pathologies are evident? What aspects of the patient’s “financial world” seem modifiable?
Financial questions should be posed colloquially. Screeners include: “Where do you live?”, “Who’s in the home?”, “How do you (all) manage financially?”, “What do you all do for a living?”, “How do you make ends meet?”, and “What financial problems are you facing?” Clinicians can quickly learn about patients’ financial self-sufficiencies, individuals for whom they bear financial responsibility, and others they rely on for support, for example, relatives. If patients avoid answering such questions forthrightly, particularly when financial arrangements are “complicated,” clinicians will want to revisit these issues later after establishing a firmer alliance but continue to wonder about the meaning of the patient’s reluctance.
When explicit, patients, families, and couples are fully aware of the conflicts but have difficulty resolving financial disputes. When conflicts are implicit, money problems may be unacknowledged, avoided, denied, or minimized. Conflicts concerning money are often transmitted trans-generationally.
Psychopathological conditions unequivocally linked to money include compulsive shopping, gambling disorders, miserly hoarding, impulse buying, and spending sprees during hypomanic and manic states. Mounting debts may create progressively insurmountable sources of distress. Money can be weaponized to sadistically create enticement, envy, or deprivation. Some monetarily antisocial individuals compromise interpersonal relationships as well as treatments. Individuals with alcohol/substance use disorders may spend so much on substances that little is left for necessities. Financially needy individuals may engage in morally questionable behaviors they might otherwise shun.
Case formulation and treatment planning
Incorporating money matters into case formulations entails demonstrating how financial concerns influenced maladaptive development and distort current attitudes, perceptions, and behaviors.
Concurrently, clinicians should acknowledge patients’ reality-based fiscal decisions, appreciating cultural and family value differences concerning how money should be acquired and spent. Since money often determines frequency and duration of treatment visits, clinicians are ethically obligated to discuss with patients what they might expect from different medications and psychotherapies, and their comparative costs.
Money matters’ impact on psychotherapies
Money matters often affect transference and countertransference reactions. Some reactions stem from how patients and clinicians compare their own financial situations with those of the other.
To help identify and ameliorate money-related countertransference responses, clinicians can reflect on questions such as: “How comfortable are you with people who are much poorer or richer than you are?” “How comfortable are you with impoverished individuals or with multimillionaires or their children?” And “why?” For trainees, all these reactions should be discussed in supervision.
Conclusions
To summarize, four clinical psychoeconomic issues should be routinely assessed and factored into psychiatric case formulations and treatment plans: how financial issues 1) have impacted patients’ psychological development; 2) impact patients’ current lives; 3) are likely to impact access, type, intensity, and duration of treatment visits; and 4) might provoke money-related transference and countertransference concerns.
In advising patients about treatment options, clinicians should discuss each treatment’s relative effectiveness and estimated costs of care. Patients’ decisions will likely be heavily influenced by financial considerations.
Dr. Yager is based in the department of psychiatry, University of Colorado at Denver, Aurora. Dr. Kay is based in the department of psychiatry, Wright State University, Dayton, Ohio. No external funds were received for this project, and the authors have no conflicts to disclose.
Reference
1. Yager J and Kay J. Money matters in psychiatric assessment, case formulation, treatment planning, and ongoing psychotherapy: Clinical psychoeconomics. J Nerv Ment Dis. 2022 Jun 10. doi: 10.1097/NMD.0000000000001552.
Long-term antidepressant use tied to an increase in CVD, mortality risk
The investigators drew on 10-year data from the UK Biobank on over 220,000 adults and compared the risk of developing adverse health outcomes among those taking antidepressants with the risk among those who were not taking antidepressants.
After adjusting for preexisting risk factors, they found that 10-year antidepressant use was associated with a twofold higher risk of CHD, an almost-twofold higher risk of CVD as well as CVD mortality, a higher risk of cerebrovascular disease, and more than double the risk of all-cause mortality.
On the other hand, at 10 years, antidepressant use was associated with a 23% lower risk of developing hypertension and a 32% lower risk of diabetes.
The main culprits were mirtazapine, venlafaxine, duloxetine, and trazodone, although SSRIs were also tied to increased risk.
“Our message for clinicians is that prescribing of antidepressants in the long term may not be harm free [and] we hope that this study will help doctors and patients have more informed conversations when they weigh up the potential risks and benefits of treatments for depression,” study investigator Narinder Bansal, MD, honorary research fellow, Centre for Academic Health and Centre for Academic Primary Care, University of Bristol (England), said in a news release.
“Regardless of whether the drugs are the underlying cause of these problems, our findings emphasize the importance of proactive cardiovascular monitoring and prevention in patients who have depression and are on antidepressants, given that both have been associated with higher risks,” she added.
The study was published online in the British Journal of Psychiatry Open.
Monitoring of CVD risk ‘critical’
Antidepressants are among the most widely prescribed drugs; 70 million prescriptions were dispensed in 2018 alone, representing a doubling of prescriptions for these agents in a decade, the investigators noted. “This striking rise in prescribing is attributed to long-term treatment rather than an increased incidence of depression.”
Most trials that have assessed antidepressant efficacy have been “poorly suited to examining adverse outcomes.” One reason for this is that many of the trials are short-term studies. Since depression is “strongly associated” with CVD risk factors, “careful assessment of the long-term cardiometabolic effects of antidepressant treatment is critical.”
Moreover, information about “a wide range of prospectively measured confounders ... is needed to provide robust estimates of the risks associated with long-term antidepressant use,” the authors noted.
The researchers examined the association between antidepressant use and four cardiometabolic morbidity outcomes – diabetes, hypertension, cerebrovascular disease, and CHD. In addition, they assessed two mortality outcomes – CVD mortality and all-cause mortality. Participants were divided into cohorts on the basis of outcome of interest.
The dataset contains detailed information on socioeconomic status, demographics, anthropometric, behavioral, and biochemical risk factors, disability, and health status and is linked to datasets of primary care records and deaths.
The study included 222,121 participants whose data had been linked to primary care records during 2018 (median age of participants, 56-57 years). About half were women, and 96% were of White ethnicity.
Participants were excluded if they had been prescribed antidepressants 12 months or less before baseline, if they had previously been diagnosed for the outcome of interest, if they had been previously prescribed psychotropic drugs, if they used cardiometabolic drugs at baseline, or if they had undergone treatment with antidepressant polytherapy.
Potential confounders included age, gender, body mass index, waist/hip ratio, smoking and alcohol intake status, physical activity, parental history of outcome, biochemical and hematologic biomarkers, socioeconomic status, and long-term illness, disability, or infirmity.
Mechanism unclear
By the end of the 5- and 10-year follow-up periods, an average of 8% and 6% of participants in each cohort, respectively, had been prescribed an antidepressant. SSRIs constituted the most commonly prescribed class (80%-82%), and citalopram was the most commonly prescribed SSRI (46%-47%). Mirtazapine was the most frequently prescribed non-SSRI antidepressant (44%-46%).
At 5 years, any antidepressant use was associated with an increased risk for diabetes, CHD, and all-cause mortality, but the findings were attenuated after further adjustment for confounders. In fact, SSRIs were associated with a reduced risk of diabetes at 5 years (hazard ratio, 0.64; 95% confidence interval, 0.49-0.83).
At 10 years, SSRIs were associated with an increased risk of cerebrovascular disease, CVD mortality, and all-cause mortality; non-SSRIs were associated with an increased risk of CHD, CVD, and all-cause mortality.
On the other hand, SSRIs were associated with a decrease in risk of diabetes and hypertension at 10 years (HR, 0.68; 95% CI, 0.53-0.87; and HR, 0.77; 95% CI, 0.66-0.89, respectively).
“While we have taken into account a wide range of pre-existing risk factors for cardiovascular disease, including those that are linked to depression such as excess weight, smoking, and low physical activity, it is difficult to fully control for the effects of depression in this kind of study, partly because there is considerable variability in the recording of depression severity in primary care,” said Dr. Bansal.
“This is important because many people taking antidepressants such as mirtazapine, venlafaxine, duloxetine and trazodone may have a more severe depression. This makes it difficult to fully separate the effects of the depression from the effects of medication,” she said.
Further research “is needed to assess whether the associations we have seen are genuinely due to the drugs; and, if so, why this might be,” she added.
Strengths, limitations
Commenting on the study, Roger McIntyre, MD, professor of psychiatry and pharmacology and head of the mood disorders psychopharmacology unit at the University of Toronto,, discussed the strengths and weaknesses of the study.
The UK Biobank is a “well-described, well-phenotyped dataset of good quality,” said Dr. McIntyre, chairperson and executive director of the Brain and Cognitive Discover Foundation, Toronto, who was not involved with the study. Another strength is the “impressive number of variables the database contains, which enabled the authors to go much deeper into the topics.”
A “significant limitation” is the confounding that is inherent to the disorder itself – “people with depression have a much higher intrinsic risk of CVD, [cerebrovascular disease], and cardiovascular mortality,” Dr. McIntyre noted.
The researchers did not adjust for trauma or childhood maltreatment, “which are the biggest risk factors for both depression and CVD; and drug and alcohol misuse were also not accounted for.”
Additionally, “to determine whether something is an association or potentially causative, it must satisfy the Bradford-Hill criteria,” said Dr. McIntyre. “Since we’re moving more toward using these big databases and because we depend on them to give us long-term perspectives, we would want to see coherent, compelling Bradford-Hill criteria regarding causation. If you don’t have any, that’s fine too, but then it’s important to make clear that there is no clear causative line, just an association.”
The research was funded by the National Institute of Health Research School for Primary Care Research and was supported by the NI Biomedical Research Centre at University Hospitals Bristol and Weston NHS Foundation Trust and the University of Bristol. Dr. McIntyre has received research grant support from CI/GACD/National Natural Science Foundation of China and the Milken Institute and speaker/consultation fees from numerous companies. Dr. McIntyre is a CEO of Braxia Scientific.
A version of this article first appeared on Medscape.com.
The investigators drew on 10-year data from the UK Biobank on over 220,000 adults and compared the risk of developing adverse health outcomes among those taking antidepressants with the risk among those who were not taking antidepressants.
After adjusting for preexisting risk factors, they found that 10-year antidepressant use was associated with a twofold higher risk of CHD, an almost-twofold higher risk of CVD as well as CVD mortality, a higher risk of cerebrovascular disease, and more than double the risk of all-cause mortality.
On the other hand, at 10 years, antidepressant use was associated with a 23% lower risk of developing hypertension and a 32% lower risk of diabetes.
The main culprits were mirtazapine, venlafaxine, duloxetine, and trazodone, although SSRIs were also tied to increased risk.
“Our message for clinicians is that prescribing of antidepressants in the long term may not be harm free [and] we hope that this study will help doctors and patients have more informed conversations when they weigh up the potential risks and benefits of treatments for depression,” study investigator Narinder Bansal, MD, honorary research fellow, Centre for Academic Health and Centre for Academic Primary Care, University of Bristol (England), said in a news release.
“Regardless of whether the drugs are the underlying cause of these problems, our findings emphasize the importance of proactive cardiovascular monitoring and prevention in patients who have depression and are on antidepressants, given that both have been associated with higher risks,” she added.
The study was published online in the British Journal of Psychiatry Open.
Monitoring of CVD risk ‘critical’
Antidepressants are among the most widely prescribed drugs; 70 million prescriptions were dispensed in 2018 alone, representing a doubling of prescriptions for these agents in a decade, the investigators noted. “This striking rise in prescribing is attributed to long-term treatment rather than an increased incidence of depression.”
Most trials that have assessed antidepressant efficacy have been “poorly suited to examining adverse outcomes.” One reason for this is that many of the trials are short-term studies. Since depression is “strongly associated” with CVD risk factors, “careful assessment of the long-term cardiometabolic effects of antidepressant treatment is critical.”
Moreover, information about “a wide range of prospectively measured confounders ... is needed to provide robust estimates of the risks associated with long-term antidepressant use,” the authors noted.
The researchers examined the association between antidepressant use and four cardiometabolic morbidity outcomes – diabetes, hypertension, cerebrovascular disease, and CHD. In addition, they assessed two mortality outcomes – CVD mortality and all-cause mortality. Participants were divided into cohorts on the basis of outcome of interest.
The dataset contains detailed information on socioeconomic status, demographics, anthropometric, behavioral, and biochemical risk factors, disability, and health status and is linked to datasets of primary care records and deaths.
The study included 222,121 participants whose data had been linked to primary care records during 2018 (median age of participants, 56-57 years). About half were women, and 96% were of White ethnicity.
Participants were excluded if they had been prescribed antidepressants 12 months or less before baseline, if they had previously been diagnosed for the outcome of interest, if they had been previously prescribed psychotropic drugs, if they used cardiometabolic drugs at baseline, or if they had undergone treatment with antidepressant polytherapy.
Potential confounders included age, gender, body mass index, waist/hip ratio, smoking and alcohol intake status, physical activity, parental history of outcome, biochemical and hematologic biomarkers, socioeconomic status, and long-term illness, disability, or infirmity.
Mechanism unclear
By the end of the 5- and 10-year follow-up periods, an average of 8% and 6% of participants in each cohort, respectively, had been prescribed an antidepressant. SSRIs constituted the most commonly prescribed class (80%-82%), and citalopram was the most commonly prescribed SSRI (46%-47%). Mirtazapine was the most frequently prescribed non-SSRI antidepressant (44%-46%).
At 5 years, any antidepressant use was associated with an increased risk for diabetes, CHD, and all-cause mortality, but the findings were attenuated after further adjustment for confounders. In fact, SSRIs were associated with a reduced risk of diabetes at 5 years (hazard ratio, 0.64; 95% confidence interval, 0.49-0.83).
At 10 years, SSRIs were associated with an increased risk of cerebrovascular disease, CVD mortality, and all-cause mortality; non-SSRIs were associated with an increased risk of CHD, CVD, and all-cause mortality.
On the other hand, SSRIs were associated with a decrease in risk of diabetes and hypertension at 10 years (HR, 0.68; 95% CI, 0.53-0.87; and HR, 0.77; 95% CI, 0.66-0.89, respectively).
“While we have taken into account a wide range of pre-existing risk factors for cardiovascular disease, including those that are linked to depression such as excess weight, smoking, and low physical activity, it is difficult to fully control for the effects of depression in this kind of study, partly because there is considerable variability in the recording of depression severity in primary care,” said Dr. Bansal.
“This is important because many people taking antidepressants such as mirtazapine, venlafaxine, duloxetine and trazodone may have a more severe depression. This makes it difficult to fully separate the effects of the depression from the effects of medication,” she said.
Further research “is needed to assess whether the associations we have seen are genuinely due to the drugs; and, if so, why this might be,” she added.
Strengths, limitations
Commenting on the study, Roger McIntyre, MD, professor of psychiatry and pharmacology and head of the mood disorders psychopharmacology unit at the University of Toronto,, discussed the strengths and weaknesses of the study.
The UK Biobank is a “well-described, well-phenotyped dataset of good quality,” said Dr. McIntyre, chairperson and executive director of the Brain and Cognitive Discover Foundation, Toronto, who was not involved with the study. Another strength is the “impressive number of variables the database contains, which enabled the authors to go much deeper into the topics.”
A “significant limitation” is the confounding that is inherent to the disorder itself – “people with depression have a much higher intrinsic risk of CVD, [cerebrovascular disease], and cardiovascular mortality,” Dr. McIntyre noted.
The researchers did not adjust for trauma or childhood maltreatment, “which are the biggest risk factors for both depression and CVD; and drug and alcohol misuse were also not accounted for.”
Additionally, “to determine whether something is an association or potentially causative, it must satisfy the Bradford-Hill criteria,” said Dr. McIntyre. “Since we’re moving more toward using these big databases and because we depend on them to give us long-term perspectives, we would want to see coherent, compelling Bradford-Hill criteria regarding causation. If you don’t have any, that’s fine too, but then it’s important to make clear that there is no clear causative line, just an association.”
The research was funded by the National Institute of Health Research School for Primary Care Research and was supported by the NI Biomedical Research Centre at University Hospitals Bristol and Weston NHS Foundation Trust and the University of Bristol. Dr. McIntyre has received research grant support from CI/GACD/National Natural Science Foundation of China and the Milken Institute and speaker/consultation fees from numerous companies. Dr. McIntyre is a CEO of Braxia Scientific.
A version of this article first appeared on Medscape.com.
The investigators drew on 10-year data from the UK Biobank on over 220,000 adults and compared the risk of developing adverse health outcomes among those taking antidepressants with the risk among those who were not taking antidepressants.
After adjusting for preexisting risk factors, they found that 10-year antidepressant use was associated with a twofold higher risk of CHD, an almost-twofold higher risk of CVD as well as CVD mortality, a higher risk of cerebrovascular disease, and more than double the risk of all-cause mortality.
On the other hand, at 10 years, antidepressant use was associated with a 23% lower risk of developing hypertension and a 32% lower risk of diabetes.
The main culprits were mirtazapine, venlafaxine, duloxetine, and trazodone, although SSRIs were also tied to increased risk.
“Our message for clinicians is that prescribing of antidepressants in the long term may not be harm free [and] we hope that this study will help doctors and patients have more informed conversations when they weigh up the potential risks and benefits of treatments for depression,” study investigator Narinder Bansal, MD, honorary research fellow, Centre for Academic Health and Centre for Academic Primary Care, University of Bristol (England), said in a news release.
“Regardless of whether the drugs are the underlying cause of these problems, our findings emphasize the importance of proactive cardiovascular monitoring and prevention in patients who have depression and are on antidepressants, given that both have been associated with higher risks,” she added.
The study was published online in the British Journal of Psychiatry Open.
Monitoring of CVD risk ‘critical’
Antidepressants are among the most widely prescribed drugs; 70 million prescriptions were dispensed in 2018 alone, representing a doubling of prescriptions for these agents in a decade, the investigators noted. “This striking rise in prescribing is attributed to long-term treatment rather than an increased incidence of depression.”
Most trials that have assessed antidepressant efficacy have been “poorly suited to examining adverse outcomes.” One reason for this is that many of the trials are short-term studies. Since depression is “strongly associated” with CVD risk factors, “careful assessment of the long-term cardiometabolic effects of antidepressant treatment is critical.”
Moreover, information about “a wide range of prospectively measured confounders ... is needed to provide robust estimates of the risks associated with long-term antidepressant use,” the authors noted.
The researchers examined the association between antidepressant use and four cardiometabolic morbidity outcomes – diabetes, hypertension, cerebrovascular disease, and CHD. In addition, they assessed two mortality outcomes – CVD mortality and all-cause mortality. Participants were divided into cohorts on the basis of outcome of interest.
The dataset contains detailed information on socioeconomic status, demographics, anthropometric, behavioral, and biochemical risk factors, disability, and health status and is linked to datasets of primary care records and deaths.
The study included 222,121 participants whose data had been linked to primary care records during 2018 (median age of participants, 56-57 years). About half were women, and 96% were of White ethnicity.
Participants were excluded if they had been prescribed antidepressants 12 months or less before baseline, if they had previously been diagnosed for the outcome of interest, if they had been previously prescribed psychotropic drugs, if they used cardiometabolic drugs at baseline, or if they had undergone treatment with antidepressant polytherapy.
Potential confounders included age, gender, body mass index, waist/hip ratio, smoking and alcohol intake status, physical activity, parental history of outcome, biochemical and hematologic biomarkers, socioeconomic status, and long-term illness, disability, or infirmity.
Mechanism unclear
By the end of the 5- and 10-year follow-up periods, an average of 8% and 6% of participants in each cohort, respectively, had been prescribed an antidepressant. SSRIs constituted the most commonly prescribed class (80%-82%), and citalopram was the most commonly prescribed SSRI (46%-47%). Mirtazapine was the most frequently prescribed non-SSRI antidepressant (44%-46%).
At 5 years, any antidepressant use was associated with an increased risk for diabetes, CHD, and all-cause mortality, but the findings were attenuated after further adjustment for confounders. In fact, SSRIs were associated with a reduced risk of diabetes at 5 years (hazard ratio, 0.64; 95% confidence interval, 0.49-0.83).
At 10 years, SSRIs were associated with an increased risk of cerebrovascular disease, CVD mortality, and all-cause mortality; non-SSRIs were associated with an increased risk of CHD, CVD, and all-cause mortality.
On the other hand, SSRIs were associated with a decrease in risk of diabetes and hypertension at 10 years (HR, 0.68; 95% CI, 0.53-0.87; and HR, 0.77; 95% CI, 0.66-0.89, respectively).
“While we have taken into account a wide range of pre-existing risk factors for cardiovascular disease, including those that are linked to depression such as excess weight, smoking, and low physical activity, it is difficult to fully control for the effects of depression in this kind of study, partly because there is considerable variability in the recording of depression severity in primary care,” said Dr. Bansal.
“This is important because many people taking antidepressants such as mirtazapine, venlafaxine, duloxetine and trazodone may have a more severe depression. This makes it difficult to fully separate the effects of the depression from the effects of medication,” she said.
Further research “is needed to assess whether the associations we have seen are genuinely due to the drugs; and, if so, why this might be,” she added.
Strengths, limitations
Commenting on the study, Roger McIntyre, MD, professor of psychiatry and pharmacology and head of the mood disorders psychopharmacology unit at the University of Toronto,, discussed the strengths and weaknesses of the study.
The UK Biobank is a “well-described, well-phenotyped dataset of good quality,” said Dr. McIntyre, chairperson and executive director of the Brain and Cognitive Discover Foundation, Toronto, who was not involved with the study. Another strength is the “impressive number of variables the database contains, which enabled the authors to go much deeper into the topics.”
A “significant limitation” is the confounding that is inherent to the disorder itself – “people with depression have a much higher intrinsic risk of CVD, [cerebrovascular disease], and cardiovascular mortality,” Dr. McIntyre noted.
The researchers did not adjust for trauma or childhood maltreatment, “which are the biggest risk factors for both depression and CVD; and drug and alcohol misuse were also not accounted for.”
Additionally, “to determine whether something is an association or potentially causative, it must satisfy the Bradford-Hill criteria,” said Dr. McIntyre. “Since we’re moving more toward using these big databases and because we depend on them to give us long-term perspectives, we would want to see coherent, compelling Bradford-Hill criteria regarding causation. If you don’t have any, that’s fine too, but then it’s important to make clear that there is no clear causative line, just an association.”
The research was funded by the National Institute of Health Research School for Primary Care Research and was supported by the NI Biomedical Research Centre at University Hospitals Bristol and Weston NHS Foundation Trust and the University of Bristol. Dr. McIntyre has received research grant support from CI/GACD/National Natural Science Foundation of China and the Milken Institute and speaker/consultation fees from numerous companies. Dr. McIntyre is a CEO of Braxia Scientific.
A version of this article first appeared on Medscape.com.
FROM THE BRITISH JOURNAL OF PSYCHIATRY OPEN
Malaria vaccine gets special delivery by tiny health personnel
Don’t like needles? Have we got a vaccine for you
Here’s a quick question: How do you turn the most annoying thing ever into something positive?
No, we’re not talking about politicians this time. No, not Elon Musk, either. Infomercials? Guess again. Humidity? Nope, even more annoying than that.
Give up? The most annoying thing ever is mosquitoes. This time, however, NPR reports that mosquitoes have been used to deliver a vaccine for the very disease they’ve been transmitting to their human food sources all these years.
In a recent proof-of-concept trial, investigators used CRISPR technology to genetically modify malaria-causing Plasmodium falciparum sporozoites, which just happen to live in the salivary glands of Anopheles mosquitoes. And since the Plasmodium parasites are already in the mosquitoes, it made sense to use the buzzy little critters as the delivery device for the vaccine.
More sense than a syringe, you ask? Have you ever tried to poke a syringe into the salivary gland of a mosquito? No, we thought not. Well, we can tell you from experience that it’s really, really hard. Never mind how we know. We just do.
The 14 study volunteers – who were paid $4,100 for their participation – were first exposed to hundreds of mosquitoes carrying the altered Plasmodium parasites. Then, to test the vaccine, they were exposed to mosquitoes that had actual, malaria-carrying Plasmodium. Half of the subjects got malaria, so the vaccine was only 50% effective, meaning there’s still work to do.
Meanwhile, the scientists here at LOTMEco are all over this mosquito-delivery business, working on a vaccine to prevent Elon Musk. Plan B involves some sort of really big swatter.
Climate change: Sleeping your life away
It’s no secret that climate change is raising the temperature on everything. You may think you’re getting relief when the sun goes down, but in some places it’s still hot. A new survey conducted in central Japan shows how bad it can be and how higher nighttime temperatures can have a serious impact on people’s health.
That online survey, the Sleep Quality Index for Daily Sleep, enabled the investigators to correlate sleep quality with daily temperature for 1,284 adults in 2011 and 2012 who completed the survey over 10 days.
Not only was there a significant difference in sleep disturbance among younger men (higher) versus older men, but the prevalence of sleep disturbance went up when the daytime temperature was above 24.8° C. They also found that disability-adjusted life-years (DALYs), which measure time lost through premature death and time lived in certain conditions that put one’s health at risk, were 81.8 years for the city of Nagoya (population, 2.2 million) in 2012.
The damage to health from sleep disorders caused by daily temperatures higher than 25° C “is comparable to that of heatstroke and must be addressed,” lead author Tomohiko Ihara of the University of Tokyo said in a written statement.
The researchers hope that this information will help sway legislators to consider the impact of higher nighttime temperatures and that it can be used to provide guidance for better sleep. The solution for now? Sleep with the air conditioner on. Your energy bill might increase, but just think about those DALYs. If using the AC lowers DALYs and increases time lived, then we say it’s worth it.
Maybe it would have been a dragon WITH cancer
If you ask a random person on the street to tell you all they know about the country of Wales, they’ll probably mention two things: One, the contorted collection of jumbled-up letters that is the Welsh language (looking at you, Llanfairpwllgwyngyllgogerychwyrndrobwllllantysiliogogogoch) and, two, the association with dragons. The Welsh flag even has a dragon on it.
With that in mind, take a guess as to what sort of statue art dealer Simon Wingett wanted to build in the Welsh town of Wrexham. No, not a monument to the second-longest place name in the world. Try again. His dragon would not be some piddly little thing either; he wanted a virtual kaiju overlooking the town, with the whole statue to stand about 60 meters high. That’s taller than the original 1954 Godzilla.
Artistic masterpieces may sell for frankly insane prices, but art dealers themselves are not the wealthiest of individuals, so Mr. Wingett needed money to fund his dragon-based dream. Lucky for him, he also happened to be the manager of a cancer charity – initially set up by Mr. Wingett’s father, who had throat cancer – which nominally aimed to provide equipment and resources to cancer patients in the Wrexham area.
Yes, this is going precisely where you think it’s going. From 2011 to 2018, when the charity closed, Mr. Wingett used the charity’s donations to fund his dragon statue – which never actually got built, by the way – to the tune of over 400,000 pounds. Of course, Mr. Wingett came under scrutiny when people started to notice that his cancer charity hadn’t actually done anything charitable since 2011, and he was recently banned by the Welsh High Court from serving as trustee of any charity for 10 years. Oh no, tragedy and horror! Truly a punishment worse than death itself.
Okay fine, he also has to pay back 117,000 pounds to actual legitimate cancer charities. The astute mathematicians out there may notice that 117,000 is a lot less than 400,000. But it’s just as the old saying goes: One-quarter of crime doesn’t pay. You can keep three-quarters of it, though, that’s completely fine.
Don’t like needles? Have we got a vaccine for you
Here’s a quick question: How do you turn the most annoying thing ever into something positive?
No, we’re not talking about politicians this time. No, not Elon Musk, either. Infomercials? Guess again. Humidity? Nope, even more annoying than that.
Give up? The most annoying thing ever is mosquitoes. This time, however, NPR reports that mosquitoes have been used to deliver a vaccine for the very disease they’ve been transmitting to their human food sources all these years.
In a recent proof-of-concept trial, investigators used CRISPR technology to genetically modify malaria-causing Plasmodium falciparum sporozoites, which just happen to live in the salivary glands of Anopheles mosquitoes. And since the Plasmodium parasites are already in the mosquitoes, it made sense to use the buzzy little critters as the delivery device for the vaccine.
More sense than a syringe, you ask? Have you ever tried to poke a syringe into the salivary gland of a mosquito? No, we thought not. Well, we can tell you from experience that it’s really, really hard. Never mind how we know. We just do.
The 14 study volunteers – who were paid $4,100 for their participation – were first exposed to hundreds of mosquitoes carrying the altered Plasmodium parasites. Then, to test the vaccine, they were exposed to mosquitoes that had actual, malaria-carrying Plasmodium. Half of the subjects got malaria, so the vaccine was only 50% effective, meaning there’s still work to do.
Meanwhile, the scientists here at LOTMEco are all over this mosquito-delivery business, working on a vaccine to prevent Elon Musk. Plan B involves some sort of really big swatter.
Climate change: Sleeping your life away
It’s no secret that climate change is raising the temperature on everything. You may think you’re getting relief when the sun goes down, but in some places it’s still hot. A new survey conducted in central Japan shows how bad it can be and how higher nighttime temperatures can have a serious impact on people’s health.
That online survey, the Sleep Quality Index for Daily Sleep, enabled the investigators to correlate sleep quality with daily temperature for 1,284 adults in 2011 and 2012 who completed the survey over 10 days.
Not only was there a significant difference in sleep disturbance among younger men (higher) versus older men, but the prevalence of sleep disturbance went up when the daytime temperature was above 24.8° C. They also found that disability-adjusted life-years (DALYs), which measure time lost through premature death and time lived in certain conditions that put one’s health at risk, were 81.8 years for the city of Nagoya (population, 2.2 million) in 2012.
The damage to health from sleep disorders caused by daily temperatures higher than 25° C “is comparable to that of heatstroke and must be addressed,” lead author Tomohiko Ihara of the University of Tokyo said in a written statement.
The researchers hope that this information will help sway legislators to consider the impact of higher nighttime temperatures and that it can be used to provide guidance for better sleep. The solution for now? Sleep with the air conditioner on. Your energy bill might increase, but just think about those DALYs. If using the AC lowers DALYs and increases time lived, then we say it’s worth it.
Maybe it would have been a dragon WITH cancer
If you ask a random person on the street to tell you all they know about the country of Wales, they’ll probably mention two things: One, the contorted collection of jumbled-up letters that is the Welsh language (looking at you, Llanfairpwllgwyngyllgogerychwyrndrobwllllantysiliogogogoch) and, two, the association with dragons. The Welsh flag even has a dragon on it.
With that in mind, take a guess as to what sort of statue art dealer Simon Wingett wanted to build in the Welsh town of Wrexham. No, not a monument to the second-longest place name in the world. Try again. His dragon would not be some piddly little thing either; he wanted a virtual kaiju overlooking the town, with the whole statue to stand about 60 meters high. That’s taller than the original 1954 Godzilla.
Artistic masterpieces may sell for frankly insane prices, but art dealers themselves are not the wealthiest of individuals, so Mr. Wingett needed money to fund his dragon-based dream. Lucky for him, he also happened to be the manager of a cancer charity – initially set up by Mr. Wingett’s father, who had throat cancer – which nominally aimed to provide equipment and resources to cancer patients in the Wrexham area.
Yes, this is going precisely where you think it’s going. From 2011 to 2018, when the charity closed, Mr. Wingett used the charity’s donations to fund his dragon statue – which never actually got built, by the way – to the tune of over 400,000 pounds. Of course, Mr. Wingett came under scrutiny when people started to notice that his cancer charity hadn’t actually done anything charitable since 2011, and he was recently banned by the Welsh High Court from serving as trustee of any charity for 10 years. Oh no, tragedy and horror! Truly a punishment worse than death itself.
Okay fine, he also has to pay back 117,000 pounds to actual legitimate cancer charities. The astute mathematicians out there may notice that 117,000 is a lot less than 400,000. But it’s just as the old saying goes: One-quarter of crime doesn’t pay. You can keep three-quarters of it, though, that’s completely fine.
Don’t like needles? Have we got a vaccine for you
Here’s a quick question: How do you turn the most annoying thing ever into something positive?
No, we’re not talking about politicians this time. No, not Elon Musk, either. Infomercials? Guess again. Humidity? Nope, even more annoying than that.
Give up? The most annoying thing ever is mosquitoes. This time, however, NPR reports that mosquitoes have been used to deliver a vaccine for the very disease they’ve been transmitting to their human food sources all these years.
In a recent proof-of-concept trial, investigators used CRISPR technology to genetically modify malaria-causing Plasmodium falciparum sporozoites, which just happen to live in the salivary glands of Anopheles mosquitoes. And since the Plasmodium parasites are already in the mosquitoes, it made sense to use the buzzy little critters as the delivery device for the vaccine.
More sense than a syringe, you ask? Have you ever tried to poke a syringe into the salivary gland of a mosquito? No, we thought not. Well, we can tell you from experience that it’s really, really hard. Never mind how we know. We just do.
The 14 study volunteers – who were paid $4,100 for their participation – were first exposed to hundreds of mosquitoes carrying the altered Plasmodium parasites. Then, to test the vaccine, they were exposed to mosquitoes that had actual, malaria-carrying Plasmodium. Half of the subjects got malaria, so the vaccine was only 50% effective, meaning there’s still work to do.
Meanwhile, the scientists here at LOTMEco are all over this mosquito-delivery business, working on a vaccine to prevent Elon Musk. Plan B involves some sort of really big swatter.
Climate change: Sleeping your life away
It’s no secret that climate change is raising the temperature on everything. You may think you’re getting relief when the sun goes down, but in some places it’s still hot. A new survey conducted in central Japan shows how bad it can be and how higher nighttime temperatures can have a serious impact on people’s health.
That online survey, the Sleep Quality Index for Daily Sleep, enabled the investigators to correlate sleep quality with daily temperature for 1,284 adults in 2011 and 2012 who completed the survey over 10 days.
Not only was there a significant difference in sleep disturbance among younger men (higher) versus older men, but the prevalence of sleep disturbance went up when the daytime temperature was above 24.8° C. They also found that disability-adjusted life-years (DALYs), which measure time lost through premature death and time lived in certain conditions that put one’s health at risk, were 81.8 years for the city of Nagoya (population, 2.2 million) in 2012.
The damage to health from sleep disorders caused by daily temperatures higher than 25° C “is comparable to that of heatstroke and must be addressed,” lead author Tomohiko Ihara of the University of Tokyo said in a written statement.
The researchers hope that this information will help sway legislators to consider the impact of higher nighttime temperatures and that it can be used to provide guidance for better sleep. The solution for now? Sleep with the air conditioner on. Your energy bill might increase, but just think about those DALYs. If using the AC lowers DALYs and increases time lived, then we say it’s worth it.
Maybe it would have been a dragon WITH cancer
If you ask a random person on the street to tell you all they know about the country of Wales, they’ll probably mention two things: One, the contorted collection of jumbled-up letters that is the Welsh language (looking at you, Llanfairpwllgwyngyllgogerychwyrndrobwllllantysiliogogogoch) and, two, the association with dragons. The Welsh flag even has a dragon on it.
With that in mind, take a guess as to what sort of statue art dealer Simon Wingett wanted to build in the Welsh town of Wrexham. No, not a monument to the second-longest place name in the world. Try again. His dragon would not be some piddly little thing either; he wanted a virtual kaiju overlooking the town, with the whole statue to stand about 60 meters high. That’s taller than the original 1954 Godzilla.
Artistic masterpieces may sell for frankly insane prices, but art dealers themselves are not the wealthiest of individuals, so Mr. Wingett needed money to fund his dragon-based dream. Lucky for him, he also happened to be the manager of a cancer charity – initially set up by Mr. Wingett’s father, who had throat cancer – which nominally aimed to provide equipment and resources to cancer patients in the Wrexham area.
Yes, this is going precisely where you think it’s going. From 2011 to 2018, when the charity closed, Mr. Wingett used the charity’s donations to fund his dragon statue – which never actually got built, by the way – to the tune of over 400,000 pounds. Of course, Mr. Wingett came under scrutiny when people started to notice that his cancer charity hadn’t actually done anything charitable since 2011, and he was recently banned by the Welsh High Court from serving as trustee of any charity for 10 years. Oh no, tragedy and horror! Truly a punishment worse than death itself.
Okay fine, he also has to pay back 117,000 pounds to actual legitimate cancer charities. The astute mathematicians out there may notice that 117,000 is a lot less than 400,000. But it’s just as the old saying goes: One-quarter of crime doesn’t pay. You can keep three-quarters of it, though, that’s completely fine.
Temper tantrums, bullying colleagues: How to avert physician misbehavior?
Daniel Freedman, DO, a pediatric neurologist in Austin, Tex., remembers being flabbergasted when a surgeon threw an instrument across the room in medical school.
“I remember thinking, ‘I can’t believe people actually do this, a grown man in his 50s having a temper tantrum,’” Dr. Freedman said in an interview. But it certainly wasn’t the last time he witnessed bad behavior by one of his peers.
The results of Medscape’s recent report, Physicians Behaving Badly: Stress and Hardship Trigger Misconduct, suggest he has plenty of company. More than 4 in 10 respondents (41%) observed inappropriate behavior in the workplace in 2022, an uptick from 35% in 2021, according to the report, which polled more than 1,500 physicians about inappropriate behavior on and off the clock.
Of course, 38% of respondents have not seen any instances of misbehavior; and many of the instances that were seen were mild or infrequent. Additionally, instances of bad behavior have declined significantly over the past 5 years.
Dr. Freedman said he learned a lesson from his mentor and program director during training that has stuck with him throughout his career. “If you couldn’t act that way at any job, whether at McDonald’s or any other possible place, you shouldn’t act that way in medicine.” But he recognizes one limitation of that advice. “A lot of the people that behave badly may not have ever worked in a different environment before,” he said.
“They only perceive that they’re at the top of the food chain, so they can behave badly without repercussions.”
What Dr. Freedman described is formally called disruptive physician behavior, one of several categories of inappropriate behavior in medicine, according to Charles Samenow, MD, MPH, an associate professor of psychiatry and behavioral sciences at George Washington University, Washington, who has studied this phenomenon for years.
“Disruptive physician behavior compromises the safety of the workplace,” Dr. Samenow explained. The behavior can occur at work, outside of work, or on social media. It can hinder operations, threaten patient and staff safety, and affect workplace morale.
“The question is trying to understand where that bad behavior is coming from and the impact of that bad behavior,” Dr. Samenow said in an interview.
One reason is fairly simple: doctors are human, and humans have a wide range of behavior. Plus, as the Medscape survey showed,
Self-selecting traits become an Achilles heel
“Any human put in a position of power over other humans has the potential to be disruptive, harass, etc, if they have certain personality traits,” said David Gorski, MD, a professor of surgery at Wayne State University, Detroit. That jibes with Dr. Samenow’s research.
Classic disruptive behavior isn’t usually associated with depression, mania, psychosis, or similar characteristics, Dr. Samenow explained. Rather, it tends to be personality driven. “Physicians are not immune to the normal problems every human being faces,” he said.
In the Medscape report, physicians cited personal arrogance as one of the leading reasons physicians engaged in inappropriate behavior (56%), followed closely by personal problems outside of work (52%), a social shift in accepting more casual behavior (50%), and job-related stress (46%). (Respondents could choose more than one answer).
One factor contributing to misbehavior that Dr. Samenow has consistently identified in his research is a history of adverse childhood experiences or family dysfunction: People who grew up in homes with physical or verbal abuse learned anger as a coping skill instead of positive, assertive communication. It’s likely that some physicians, as well as the overall population, learned anger as a coping skill for that reason.
How to help avert disruptive behavior in medical settings
Dr. Samenow said that coaching is a “wonderful tool” in teaching the interpersonal skills that medical school often doesn’t address.
In some case, interventions can be very helpful. For example, programs that teach effective communication strategies and teamwork through a combination of culturally sensitive dialectical and cognitive-behavioral therapy and other modalities have been successful, Dr. Samenow said. Although they are more about treating an illness than addressing “misbehavior,” programs for substance use that have been developed by and for doctors are very effective, too.
Fewer resources are available, however, for addressing racism, classism, misogyny, and other forms of bigotry, Dr. Samenow noted. “There’s implicit bias training, but not at the level of what exists for disruptive physicians and those with addiction. “That’s an area we need to work on.” Racist language was the third most commonly observed bad behavior cited in the Medscape survey, behind only bullying of staff and mocking or disparaging of patients. It was reported frequently outside of work as well.
The Medscape report found an increase in observed behavior at work and on social media, although it’s hard to determine prevalence trends over time, Dr. Samenow said. “The tolerance for this behavior has really gone down,” likely leading to more reporting, he said, and more systems for reporting bad behavior exist today than in the past.
However, Dr. Freedman said inadequate regulation, disciplinary action, and follow-through remain a problem.
“There are lots of limitations to our reporting system and to our follow-through with those reports,” including hospitals that, whether for fear of litigation or other reasons, allow physicians to quietly resign and move to another institution, even with positive recommendations, Dr. Freedman said.
Indeed, only a third of observed misbehavior in the Medscape report resulted in disciplinary action. Half the respondents believed a verbal warning was a necessary consequence, followed by a conversation from management and being reported to a supervisor or human resources. Though only 10% thought a report to the medical board was warranted, it likely depends on the offense and its frequency.
“I think going from paternalism to more patient-centered care and having patients involved in those conversations is a nice shift that makes doctors more human and relatable, and hopefully makes the public more forgiving, that we’re going to make mistakes and nobody’s perfect,” Freedman said. But he added that physicians should be held accountable when a mistake or two becomes a pattern.
Misinformation is professional misconduct
Sufficient accountability is especially absent, these doctors said, for a subset of professional misconduct: spreading misinformation.
While more “conventional” bad behaviors include fraud, dishonesty, abuse of underlings, and incompetence, bad behavior should also include “selling quackery and antivaccine misinformation, the way some doctors did with various nostrums for COVID-19,” said Dr. Gorski, who frequently blogs about doctors’ spreading misinformation.
Taylor Nichols, MD, an emergency medicine physician based in Sacramento, cites the desire for attention and clout as motivations. “Saying things that are wildly, provably false is professional misconduct,” Nichols said. He distinguished such statements from scientific, academic, or clinical disagreement that is necessary within medicine.
Yet there’s been a “long tradition of looking the other way or letting people with fancy titles get away with saying nonsense just because they’re respected,” Jonathan Howard, MD, an associate professor of psychiatry and neurology at New York University said in an interview.
“We have a duty to be trusted members of the community,” Dr. Howard said. “People listen when we say things, and we have an obligation to try to be accurate and humble and as honest as possible and admit mistakes when we inevitably make them.”
That extends to social media, which Dr. Nichols said has magnified the problem of promoting quackery and misinformation. He thinks medical boards and professional credentialing bodies should pay attention to what’s happening in the public conversation and understand that our professional responsibility extends beyond the walls of the hospital or clinic. Physicians must represent themselves professionally and uphold the standards that the profession expects.
On the one hand, Medscape respondents agreed: 70% said one doctor’s misbehavior taints the whole profession. Yet, at the same time, 58% of respondents believed physicians should be able to “keep their private lives private” in 2022. But that’s not the reality of the profession when the lines between private life and behavior away from work get blurred, Dr. Samenow said.
“The way a physician behaves in public represents you,” he said. “What happens in Vegas doesn’t always stay in Vegas.”
A version of this article first appeared on Medscape.com.
Daniel Freedman, DO, a pediatric neurologist in Austin, Tex., remembers being flabbergasted when a surgeon threw an instrument across the room in medical school.
“I remember thinking, ‘I can’t believe people actually do this, a grown man in his 50s having a temper tantrum,’” Dr. Freedman said in an interview. But it certainly wasn’t the last time he witnessed bad behavior by one of his peers.
The results of Medscape’s recent report, Physicians Behaving Badly: Stress and Hardship Trigger Misconduct, suggest he has plenty of company. More than 4 in 10 respondents (41%) observed inappropriate behavior in the workplace in 2022, an uptick from 35% in 2021, according to the report, which polled more than 1,500 physicians about inappropriate behavior on and off the clock.
Of course, 38% of respondents have not seen any instances of misbehavior; and many of the instances that were seen were mild or infrequent. Additionally, instances of bad behavior have declined significantly over the past 5 years.
Dr. Freedman said he learned a lesson from his mentor and program director during training that has stuck with him throughout his career. “If you couldn’t act that way at any job, whether at McDonald’s or any other possible place, you shouldn’t act that way in medicine.” But he recognizes one limitation of that advice. “A lot of the people that behave badly may not have ever worked in a different environment before,” he said.
“They only perceive that they’re at the top of the food chain, so they can behave badly without repercussions.”
What Dr. Freedman described is formally called disruptive physician behavior, one of several categories of inappropriate behavior in medicine, according to Charles Samenow, MD, MPH, an associate professor of psychiatry and behavioral sciences at George Washington University, Washington, who has studied this phenomenon for years.
“Disruptive physician behavior compromises the safety of the workplace,” Dr. Samenow explained. The behavior can occur at work, outside of work, or on social media. It can hinder operations, threaten patient and staff safety, and affect workplace morale.
“The question is trying to understand where that bad behavior is coming from and the impact of that bad behavior,” Dr. Samenow said in an interview.
One reason is fairly simple: doctors are human, and humans have a wide range of behavior. Plus, as the Medscape survey showed,
Self-selecting traits become an Achilles heel
“Any human put in a position of power over other humans has the potential to be disruptive, harass, etc, if they have certain personality traits,” said David Gorski, MD, a professor of surgery at Wayne State University, Detroit. That jibes with Dr. Samenow’s research.
Classic disruptive behavior isn’t usually associated with depression, mania, psychosis, or similar characteristics, Dr. Samenow explained. Rather, it tends to be personality driven. “Physicians are not immune to the normal problems every human being faces,” he said.
In the Medscape report, physicians cited personal arrogance as one of the leading reasons physicians engaged in inappropriate behavior (56%), followed closely by personal problems outside of work (52%), a social shift in accepting more casual behavior (50%), and job-related stress (46%). (Respondents could choose more than one answer).
One factor contributing to misbehavior that Dr. Samenow has consistently identified in his research is a history of adverse childhood experiences or family dysfunction: People who grew up in homes with physical or verbal abuse learned anger as a coping skill instead of positive, assertive communication. It’s likely that some physicians, as well as the overall population, learned anger as a coping skill for that reason.
How to help avert disruptive behavior in medical settings
Dr. Samenow said that coaching is a “wonderful tool” in teaching the interpersonal skills that medical school often doesn’t address.
In some case, interventions can be very helpful. For example, programs that teach effective communication strategies and teamwork through a combination of culturally sensitive dialectical and cognitive-behavioral therapy and other modalities have been successful, Dr. Samenow said. Although they are more about treating an illness than addressing “misbehavior,” programs for substance use that have been developed by and for doctors are very effective, too.
Fewer resources are available, however, for addressing racism, classism, misogyny, and other forms of bigotry, Dr. Samenow noted. “There’s implicit bias training, but not at the level of what exists for disruptive physicians and those with addiction. “That’s an area we need to work on.” Racist language was the third most commonly observed bad behavior cited in the Medscape survey, behind only bullying of staff and mocking or disparaging of patients. It was reported frequently outside of work as well.
The Medscape report found an increase in observed behavior at work and on social media, although it’s hard to determine prevalence trends over time, Dr. Samenow said. “The tolerance for this behavior has really gone down,” likely leading to more reporting, he said, and more systems for reporting bad behavior exist today than in the past.
However, Dr. Freedman said inadequate regulation, disciplinary action, and follow-through remain a problem.
“There are lots of limitations to our reporting system and to our follow-through with those reports,” including hospitals that, whether for fear of litigation or other reasons, allow physicians to quietly resign and move to another institution, even with positive recommendations, Dr. Freedman said.
Indeed, only a third of observed misbehavior in the Medscape report resulted in disciplinary action. Half the respondents believed a verbal warning was a necessary consequence, followed by a conversation from management and being reported to a supervisor or human resources. Though only 10% thought a report to the medical board was warranted, it likely depends on the offense and its frequency.
“I think going from paternalism to more patient-centered care and having patients involved in those conversations is a nice shift that makes doctors more human and relatable, and hopefully makes the public more forgiving, that we’re going to make mistakes and nobody’s perfect,” Freedman said. But he added that physicians should be held accountable when a mistake or two becomes a pattern.
Misinformation is professional misconduct
Sufficient accountability is especially absent, these doctors said, for a subset of professional misconduct: spreading misinformation.
While more “conventional” bad behaviors include fraud, dishonesty, abuse of underlings, and incompetence, bad behavior should also include “selling quackery and antivaccine misinformation, the way some doctors did with various nostrums for COVID-19,” said Dr. Gorski, who frequently blogs about doctors’ spreading misinformation.
Taylor Nichols, MD, an emergency medicine physician based in Sacramento, cites the desire for attention and clout as motivations. “Saying things that are wildly, provably false is professional misconduct,” Nichols said. He distinguished such statements from scientific, academic, or clinical disagreement that is necessary within medicine.
Yet there’s been a “long tradition of looking the other way or letting people with fancy titles get away with saying nonsense just because they’re respected,” Jonathan Howard, MD, an associate professor of psychiatry and neurology at New York University said in an interview.
“We have a duty to be trusted members of the community,” Dr. Howard said. “People listen when we say things, and we have an obligation to try to be accurate and humble and as honest as possible and admit mistakes when we inevitably make them.”
That extends to social media, which Dr. Nichols said has magnified the problem of promoting quackery and misinformation. He thinks medical boards and professional credentialing bodies should pay attention to what’s happening in the public conversation and understand that our professional responsibility extends beyond the walls of the hospital or clinic. Physicians must represent themselves professionally and uphold the standards that the profession expects.
On the one hand, Medscape respondents agreed: 70% said one doctor’s misbehavior taints the whole profession. Yet, at the same time, 58% of respondents believed physicians should be able to “keep their private lives private” in 2022. But that’s not the reality of the profession when the lines between private life and behavior away from work get blurred, Dr. Samenow said.
“The way a physician behaves in public represents you,” he said. “What happens in Vegas doesn’t always stay in Vegas.”
A version of this article first appeared on Medscape.com.
Daniel Freedman, DO, a pediatric neurologist in Austin, Tex., remembers being flabbergasted when a surgeon threw an instrument across the room in medical school.
“I remember thinking, ‘I can’t believe people actually do this, a grown man in his 50s having a temper tantrum,’” Dr. Freedman said in an interview. But it certainly wasn’t the last time he witnessed bad behavior by one of his peers.
The results of Medscape’s recent report, Physicians Behaving Badly: Stress and Hardship Trigger Misconduct, suggest he has plenty of company. More than 4 in 10 respondents (41%) observed inappropriate behavior in the workplace in 2022, an uptick from 35% in 2021, according to the report, which polled more than 1,500 physicians about inappropriate behavior on and off the clock.
Of course, 38% of respondents have not seen any instances of misbehavior; and many of the instances that were seen were mild or infrequent. Additionally, instances of bad behavior have declined significantly over the past 5 years.
Dr. Freedman said he learned a lesson from his mentor and program director during training that has stuck with him throughout his career. “If you couldn’t act that way at any job, whether at McDonald’s or any other possible place, you shouldn’t act that way in medicine.” But he recognizes one limitation of that advice. “A lot of the people that behave badly may not have ever worked in a different environment before,” he said.
“They only perceive that they’re at the top of the food chain, so they can behave badly without repercussions.”
What Dr. Freedman described is formally called disruptive physician behavior, one of several categories of inappropriate behavior in medicine, according to Charles Samenow, MD, MPH, an associate professor of psychiatry and behavioral sciences at George Washington University, Washington, who has studied this phenomenon for years.
“Disruptive physician behavior compromises the safety of the workplace,” Dr. Samenow explained. The behavior can occur at work, outside of work, or on social media. It can hinder operations, threaten patient and staff safety, and affect workplace morale.
“The question is trying to understand where that bad behavior is coming from and the impact of that bad behavior,” Dr. Samenow said in an interview.
One reason is fairly simple: doctors are human, and humans have a wide range of behavior. Plus, as the Medscape survey showed,
Self-selecting traits become an Achilles heel
“Any human put in a position of power over other humans has the potential to be disruptive, harass, etc, if they have certain personality traits,” said David Gorski, MD, a professor of surgery at Wayne State University, Detroit. That jibes with Dr. Samenow’s research.
Classic disruptive behavior isn’t usually associated with depression, mania, psychosis, or similar characteristics, Dr. Samenow explained. Rather, it tends to be personality driven. “Physicians are not immune to the normal problems every human being faces,” he said.
In the Medscape report, physicians cited personal arrogance as one of the leading reasons physicians engaged in inappropriate behavior (56%), followed closely by personal problems outside of work (52%), a social shift in accepting more casual behavior (50%), and job-related stress (46%). (Respondents could choose more than one answer).
One factor contributing to misbehavior that Dr. Samenow has consistently identified in his research is a history of adverse childhood experiences or family dysfunction: People who grew up in homes with physical or verbal abuse learned anger as a coping skill instead of positive, assertive communication. It’s likely that some physicians, as well as the overall population, learned anger as a coping skill for that reason.
How to help avert disruptive behavior in medical settings
Dr. Samenow said that coaching is a “wonderful tool” in teaching the interpersonal skills that medical school often doesn’t address.
In some case, interventions can be very helpful. For example, programs that teach effective communication strategies and teamwork through a combination of culturally sensitive dialectical and cognitive-behavioral therapy and other modalities have been successful, Dr. Samenow said. Although they are more about treating an illness than addressing “misbehavior,” programs for substance use that have been developed by and for doctors are very effective, too.
Fewer resources are available, however, for addressing racism, classism, misogyny, and other forms of bigotry, Dr. Samenow noted. “There’s implicit bias training, but not at the level of what exists for disruptive physicians and those with addiction. “That’s an area we need to work on.” Racist language was the third most commonly observed bad behavior cited in the Medscape survey, behind only bullying of staff and mocking or disparaging of patients. It was reported frequently outside of work as well.
The Medscape report found an increase in observed behavior at work and on social media, although it’s hard to determine prevalence trends over time, Dr. Samenow said. “The tolerance for this behavior has really gone down,” likely leading to more reporting, he said, and more systems for reporting bad behavior exist today than in the past.
However, Dr. Freedman said inadequate regulation, disciplinary action, and follow-through remain a problem.
“There are lots of limitations to our reporting system and to our follow-through with those reports,” including hospitals that, whether for fear of litigation or other reasons, allow physicians to quietly resign and move to another institution, even with positive recommendations, Dr. Freedman said.
Indeed, only a third of observed misbehavior in the Medscape report resulted in disciplinary action. Half the respondents believed a verbal warning was a necessary consequence, followed by a conversation from management and being reported to a supervisor or human resources. Though only 10% thought a report to the medical board was warranted, it likely depends on the offense and its frequency.
“I think going from paternalism to more patient-centered care and having patients involved in those conversations is a nice shift that makes doctors more human and relatable, and hopefully makes the public more forgiving, that we’re going to make mistakes and nobody’s perfect,” Freedman said. But he added that physicians should be held accountable when a mistake or two becomes a pattern.
Misinformation is professional misconduct
Sufficient accountability is especially absent, these doctors said, for a subset of professional misconduct: spreading misinformation.
While more “conventional” bad behaviors include fraud, dishonesty, abuse of underlings, and incompetence, bad behavior should also include “selling quackery and antivaccine misinformation, the way some doctors did with various nostrums for COVID-19,” said Dr. Gorski, who frequently blogs about doctors’ spreading misinformation.
Taylor Nichols, MD, an emergency medicine physician based in Sacramento, cites the desire for attention and clout as motivations. “Saying things that are wildly, provably false is professional misconduct,” Nichols said. He distinguished such statements from scientific, academic, or clinical disagreement that is necessary within medicine.
Yet there’s been a “long tradition of looking the other way or letting people with fancy titles get away with saying nonsense just because they’re respected,” Jonathan Howard, MD, an associate professor of psychiatry and neurology at New York University said in an interview.
“We have a duty to be trusted members of the community,” Dr. Howard said. “People listen when we say things, and we have an obligation to try to be accurate and humble and as honest as possible and admit mistakes when we inevitably make them.”
That extends to social media, which Dr. Nichols said has magnified the problem of promoting quackery and misinformation. He thinks medical boards and professional credentialing bodies should pay attention to what’s happening in the public conversation and understand that our professional responsibility extends beyond the walls of the hospital or clinic. Physicians must represent themselves professionally and uphold the standards that the profession expects.
On the one hand, Medscape respondents agreed: 70% said one doctor’s misbehavior taints the whole profession. Yet, at the same time, 58% of respondents believed physicians should be able to “keep their private lives private” in 2022. But that’s not the reality of the profession when the lines between private life and behavior away from work get blurred, Dr. Samenow said.
“The way a physician behaves in public represents you,” he said. “What happens in Vegas doesn’t always stay in Vegas.”
A version of this article first appeared on Medscape.com.
Long-acting naltrexone effective in alcohol use disorder
findings presented at the annual meeting of the American College of Emergency Physicians.
according toThe results show the feasibility of such a program and underscore the importance of the ED in combating AUD, said the researchers, from the University of California, San Francisco.
“According to the National Institute on Alcohol Abuse and Alcoholism, 18% of ED visits had alcohol as a contributing factor – the volume of alcohol-related ED visits has been climbing every year, and it is a significant public health problem,” said Maria Raven, MD, MPH, professor of emergency medicine at UCSF. “Right now, we do very little for people who come to the ED with AUD, so it is a missed opportunity to intervene, especially given the volume of visits we see and that our patient population is one that often has significant barriers to accessing outpatient treatment.”
The findings come from a 12-week, prospective, single-arm study of ED patients who were actively drinking adults with known or suspected AUD and who had positive scores on a screening test. Of 179 patients who were approached, 32 agreed to enroll; the enrollment yield was 18%. Participants were given monthly extended-release naltrexone and case management services.
Of the 32 participants, 25 completed all their study visits and 22 (69%) continued taking naltrexone after the 12 weeks.
The researchers said the results surprised them. The average daily alcohol consumption at baseline was 7.6 drinks a day, and it fell by 7.5 drinks a day – in other words, to almost no consumption.
“The median alcohol consumption when measured over the last 2 weeks of the study was zero,” Dr. Raven said. “This doesn’t mean everyone was at zero, but this was the median and reflects that many participants stopped drinking altogether. We were pleasantly surprised by this. I don’t know that we thought so many people who participated would actually fully abstain.”
On the Kemp Quality of Life Scale – with scores from 1 to 7, with 1 being “life is very distressing,” 4 being “life is so-so,” and 7 being “life is great” – the average baseline score was 3.6. That score rose by 1.2 points by the study’s end.
Dr. Raven said she hoped more would enroll but that “a number of people actually did not want the injection or were not ready to think about stopping.” Still, the 18% enrollment is “a major improvement,” considering that no attempt was made to initiate treatment with naltrexone prior to the study. Oral naltrexone, rather than the injection, could be offered to improve participation, but oral naltrexone has to be taken daily.
She said a larger study is planned at UCSF and that other institutions are interested in starting a similar program.
“When someone is in the ED for an AUD-related issue, it can serve as a turning point for them in some cases,” she said.
Erik S. Anderson, MD, associate research director at Oakland, Calif.–based Alameda Health System, who has studied naltrexone in the ED, said the findings dovetail with what his team has found at his center. He added that psychosocial support is important as well and that his team has found that navigation services are the most important factor in connecting patients with follow-up care – even more so than providing medications.
“In my mind, this is a situation where we have treatment options and approaches that work, and it’s really about implementing these services in a novel care setting,” he said. “ED patients are at higher risk of complications for AUD simply because they are in the ED in the first place – initiating AUD treatment in this setting is the right thing to do.”
Dr. Raven and Dr. Anderson disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
findings presented at the annual meeting of the American College of Emergency Physicians.
according toThe results show the feasibility of such a program and underscore the importance of the ED in combating AUD, said the researchers, from the University of California, San Francisco.
“According to the National Institute on Alcohol Abuse and Alcoholism, 18% of ED visits had alcohol as a contributing factor – the volume of alcohol-related ED visits has been climbing every year, and it is a significant public health problem,” said Maria Raven, MD, MPH, professor of emergency medicine at UCSF. “Right now, we do very little for people who come to the ED with AUD, so it is a missed opportunity to intervene, especially given the volume of visits we see and that our patient population is one that often has significant barriers to accessing outpatient treatment.”
The findings come from a 12-week, prospective, single-arm study of ED patients who were actively drinking adults with known or suspected AUD and who had positive scores on a screening test. Of 179 patients who were approached, 32 agreed to enroll; the enrollment yield was 18%. Participants were given monthly extended-release naltrexone and case management services.
Of the 32 participants, 25 completed all their study visits and 22 (69%) continued taking naltrexone after the 12 weeks.
The researchers said the results surprised them. The average daily alcohol consumption at baseline was 7.6 drinks a day, and it fell by 7.5 drinks a day – in other words, to almost no consumption.
“The median alcohol consumption when measured over the last 2 weeks of the study was zero,” Dr. Raven said. “This doesn’t mean everyone was at zero, but this was the median and reflects that many participants stopped drinking altogether. We were pleasantly surprised by this. I don’t know that we thought so many people who participated would actually fully abstain.”
On the Kemp Quality of Life Scale – with scores from 1 to 7, with 1 being “life is very distressing,” 4 being “life is so-so,” and 7 being “life is great” – the average baseline score was 3.6. That score rose by 1.2 points by the study’s end.
Dr. Raven said she hoped more would enroll but that “a number of people actually did not want the injection or were not ready to think about stopping.” Still, the 18% enrollment is “a major improvement,” considering that no attempt was made to initiate treatment with naltrexone prior to the study. Oral naltrexone, rather than the injection, could be offered to improve participation, but oral naltrexone has to be taken daily.
She said a larger study is planned at UCSF and that other institutions are interested in starting a similar program.
“When someone is in the ED for an AUD-related issue, it can serve as a turning point for them in some cases,” she said.
Erik S. Anderson, MD, associate research director at Oakland, Calif.–based Alameda Health System, who has studied naltrexone in the ED, said the findings dovetail with what his team has found at his center. He added that psychosocial support is important as well and that his team has found that navigation services are the most important factor in connecting patients with follow-up care – even more so than providing medications.
“In my mind, this is a situation where we have treatment options and approaches that work, and it’s really about implementing these services in a novel care setting,” he said. “ED patients are at higher risk of complications for AUD simply because they are in the ED in the first place – initiating AUD treatment in this setting is the right thing to do.”
Dr. Raven and Dr. Anderson disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
findings presented at the annual meeting of the American College of Emergency Physicians.
according toThe results show the feasibility of such a program and underscore the importance of the ED in combating AUD, said the researchers, from the University of California, San Francisco.
“According to the National Institute on Alcohol Abuse and Alcoholism, 18% of ED visits had alcohol as a contributing factor – the volume of alcohol-related ED visits has been climbing every year, and it is a significant public health problem,” said Maria Raven, MD, MPH, professor of emergency medicine at UCSF. “Right now, we do very little for people who come to the ED with AUD, so it is a missed opportunity to intervene, especially given the volume of visits we see and that our patient population is one that often has significant barriers to accessing outpatient treatment.”
The findings come from a 12-week, prospective, single-arm study of ED patients who were actively drinking adults with known or suspected AUD and who had positive scores on a screening test. Of 179 patients who were approached, 32 agreed to enroll; the enrollment yield was 18%. Participants were given monthly extended-release naltrexone and case management services.
Of the 32 participants, 25 completed all their study visits and 22 (69%) continued taking naltrexone after the 12 weeks.
The researchers said the results surprised them. The average daily alcohol consumption at baseline was 7.6 drinks a day, and it fell by 7.5 drinks a day – in other words, to almost no consumption.
“The median alcohol consumption when measured over the last 2 weeks of the study was zero,” Dr. Raven said. “This doesn’t mean everyone was at zero, but this was the median and reflects that many participants stopped drinking altogether. We were pleasantly surprised by this. I don’t know that we thought so many people who participated would actually fully abstain.”
On the Kemp Quality of Life Scale – with scores from 1 to 7, with 1 being “life is very distressing,” 4 being “life is so-so,” and 7 being “life is great” – the average baseline score was 3.6. That score rose by 1.2 points by the study’s end.
Dr. Raven said she hoped more would enroll but that “a number of people actually did not want the injection or were not ready to think about stopping.” Still, the 18% enrollment is “a major improvement,” considering that no attempt was made to initiate treatment with naltrexone prior to the study. Oral naltrexone, rather than the injection, could be offered to improve participation, but oral naltrexone has to be taken daily.
She said a larger study is planned at UCSF and that other institutions are interested in starting a similar program.
“When someone is in the ED for an AUD-related issue, it can serve as a turning point for them in some cases,” she said.
Erik S. Anderson, MD, associate research director at Oakland, Calif.–based Alameda Health System, who has studied naltrexone in the ED, said the findings dovetail with what his team has found at his center. He added that psychosocial support is important as well and that his team has found that navigation services are the most important factor in connecting patients with follow-up care – even more so than providing medications.
“In my mind, this is a situation where we have treatment options and approaches that work, and it’s really about implementing these services in a novel care setting,” he said. “ED patients are at higher risk of complications for AUD simply because they are in the ED in the first place – initiating AUD treatment in this setting is the right thing to do.”
Dr. Raven and Dr. Anderson disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
FROM ACEP 2022
I am not fine: The heavy toll cancer takes
PARIS – “I thought I was as exhausted, and isolated, and neglected as I could get, and then he came home.”
Those were the words of Kate Washington, PhD, from Sacramento as she gave a moving account of the immense burden she felt as caregiver to her husband with cancer.
She was taking part in the session, “I am FINE: Frustrated * Isolated * Neglected * Emotional,” at the annual meeting of the European Society for Medical Oncology. In that session,
Dr. Washington, author of “Already Toast: Caregiving and Burnout in America” (Boston: Beacon Press, 2021), explained that she cared for her husband and young family while he was “suffering through two different kinds of lymphoma and really devastating stem cell transplants.”
When her husband was first diagnosed with a rare form of lymphoma in 2015, he was placed on a watch-and-wait protocol. At that point, he seemed fine, Dr. Washington said.
A few months later, he started coughing up blood. After being rushed to the emergency department, doctors found that a slow-growing lung tumor had ruptured.
Three weeks later, he came out of the hospital with a collapsed lung – an effect of his chemotherapy, Dr. Washington said.
But that was hardly the last word. He soon experienced relapse with a “very aggressive” form of his disease, and in 2016, he underwent a stem cell transplant.
“He spent 1½ months in the hospital ... in isolation, not seeing our daughters,” Dr. Washington said. He lost his vision and developed grade 4 graft-versus-host disease, among other problems.
He was alive, just barely, Dr. Washington said.
“As you might imagine, I was pulled between the hospital and the home, taking care of our daughters, who were not seeing him during that time,” she recalled.
But every time someone asked her whether she was okay, she replied: “I am fine.”
“A total lie,” she admitted.
Dr. Washington felt frustrated, not only from the financial strain of out-of-pocket health care costs and lost earnings but also from fast evolving relationships and a feeling of being “unseen and underappreciated.”
Another jarring change: When her husband was discharged from the hospital, Dr. Washington was suddenly thrust into the role of full-time caretaker.
Her husband could not be left alone, his doctor had said. And with two young children, Dr. Washington did not know how she would manage.
The demands of being a full-time caregiver are intense. Caregivers, Dr. Washington explained, can spend 32 hours a week looking after a loved one with cancer.
Like Dr. Washington, most caregivers feel they have no choice but to take on this intense role – one for which they have little or no training or preparation. The nonstop demands leave little time for self-care and can lead to high rates of caregiver injury and illness.
Isolation often creeps in because it can be “hard to ask for help,” she said. About 30% of caregivers report having depression or anxiety, and 21% feel lonely.
“When he was very ill, I found it really difficult to connect with other people and my friends,” Dr. Washington recalled. “I didn’t feel like I could really adequately explain the kind of strain that I was under.”
Are patients fine?
Like caregivers, patients often say they are fine when they are not.
The toll cancer takes on patients is immense. Natacha Bolanos Fernandez, from the Lymphoma Coalition Europe, highlighted the physical, mental, and social strain that can affect patients with cancer.
The physical aspects can encompass a host of problems – fatigue, night sweats, weight loss, and the vomiting that accompanies many cancer treatments. Patients may face changes in their mobility and independence as well. The mental side of cancer can include anxiety, depression, and psychological distress, while the social aspects span changing, perhaps strained, relationships with family and friends.
Fatigue, in particular, is an underreported, underdiagnosed, and undertreated problem, Ms. Fernandez noted. According to recent survey data from the Lymphoma Coalition’s Global Patient Survey, 72% of patients reported fatigue. This problem worsened over time, with 59% reporting fatigue after their diagnosis and up to 82% among patients who experienced relapse two or more times.
Fatigue “may be getting worse rather than better over time,” Ms. Fernandez said, and many patients felt that their life had changed completely because of cancer-related fatigue.
To help patients manage, the Lymphoma Coalition has published a report on the impact of cancer-related fatigue and how to improve outcomes. Methods include greater awareness, regular screening, and interventions such as yoga or mindfulness-based cognitive therapy.
Are clinicians fine?
Nurses and physicians face challenges caring for patients with cancer.
Although “nurses love their jobs and are extremely committed,” the impact cancer has on a nursing career is often undervalued or “neglected,” said Lena Sharp, RN, PhD, of the Regional Cancer Centre, Stockholm-Gotland.
Burnout, in particular, remains a problem among oncologists and nurses, and it was made worse during the COVID-19 pandemic.
Fatima Cardoso, MD, explained that burnout has an impact on doctors as well as patients because it affects communication with patients and performance. Physicians can, for instance, appear detached, emotional, or tired.
Patients may then feel less inclined to tell their oncologist how they’re feeling, said Dr. Cardoso, director of the breast unit at Champalimaud Clinical Center, Lisbon.
It is important to remember to not just focus on the patient’s disease or treatment but to also ask how they are doing and what is going on in their lives.
Above all, “show that you care,” said Dr. Cardoso.
The Lymphoma Coalition Europe has relationships with Bristol-Myers Squibb, Establishment Labs, Kyowa Kirin, Novartis, Roche, Takeda. Dr. Cardoso has relationships with Amgen, Astellas/Medivation, AstraZeneca, Celgene, Daiichi Sankyo, Eisai, GE Oncology, Genentech, GlaxoSmithKline, and other companies. No other relevant financial relationships were reported.
A version of this article first appeared on Medscape.com.
PARIS – “I thought I was as exhausted, and isolated, and neglected as I could get, and then he came home.”
Those were the words of Kate Washington, PhD, from Sacramento as she gave a moving account of the immense burden she felt as caregiver to her husband with cancer.
She was taking part in the session, “I am FINE: Frustrated * Isolated * Neglected * Emotional,” at the annual meeting of the European Society for Medical Oncology. In that session,
Dr. Washington, author of “Already Toast: Caregiving and Burnout in America” (Boston: Beacon Press, 2021), explained that she cared for her husband and young family while he was “suffering through two different kinds of lymphoma and really devastating stem cell transplants.”
When her husband was first diagnosed with a rare form of lymphoma in 2015, he was placed on a watch-and-wait protocol. At that point, he seemed fine, Dr. Washington said.
A few months later, he started coughing up blood. After being rushed to the emergency department, doctors found that a slow-growing lung tumor had ruptured.
Three weeks later, he came out of the hospital with a collapsed lung – an effect of his chemotherapy, Dr. Washington said.
But that was hardly the last word. He soon experienced relapse with a “very aggressive” form of his disease, and in 2016, he underwent a stem cell transplant.
“He spent 1½ months in the hospital ... in isolation, not seeing our daughters,” Dr. Washington said. He lost his vision and developed grade 4 graft-versus-host disease, among other problems.
He was alive, just barely, Dr. Washington said.
“As you might imagine, I was pulled between the hospital and the home, taking care of our daughters, who were not seeing him during that time,” she recalled.
But every time someone asked her whether she was okay, she replied: “I am fine.”
“A total lie,” she admitted.
Dr. Washington felt frustrated, not only from the financial strain of out-of-pocket health care costs and lost earnings but also from fast evolving relationships and a feeling of being “unseen and underappreciated.”
Another jarring change: When her husband was discharged from the hospital, Dr. Washington was suddenly thrust into the role of full-time caretaker.
Her husband could not be left alone, his doctor had said. And with two young children, Dr. Washington did not know how she would manage.
The demands of being a full-time caregiver are intense. Caregivers, Dr. Washington explained, can spend 32 hours a week looking after a loved one with cancer.
Like Dr. Washington, most caregivers feel they have no choice but to take on this intense role – one for which they have little or no training or preparation. The nonstop demands leave little time for self-care and can lead to high rates of caregiver injury and illness.
Isolation often creeps in because it can be “hard to ask for help,” she said. About 30% of caregivers report having depression or anxiety, and 21% feel lonely.
“When he was very ill, I found it really difficult to connect with other people and my friends,” Dr. Washington recalled. “I didn’t feel like I could really adequately explain the kind of strain that I was under.”
Are patients fine?
Like caregivers, patients often say they are fine when they are not.
The toll cancer takes on patients is immense. Natacha Bolanos Fernandez, from the Lymphoma Coalition Europe, highlighted the physical, mental, and social strain that can affect patients with cancer.
The physical aspects can encompass a host of problems – fatigue, night sweats, weight loss, and the vomiting that accompanies many cancer treatments. Patients may face changes in their mobility and independence as well. The mental side of cancer can include anxiety, depression, and psychological distress, while the social aspects span changing, perhaps strained, relationships with family and friends.
Fatigue, in particular, is an underreported, underdiagnosed, and undertreated problem, Ms. Fernandez noted. According to recent survey data from the Lymphoma Coalition’s Global Patient Survey, 72% of patients reported fatigue. This problem worsened over time, with 59% reporting fatigue after their diagnosis and up to 82% among patients who experienced relapse two or more times.
Fatigue “may be getting worse rather than better over time,” Ms. Fernandez said, and many patients felt that their life had changed completely because of cancer-related fatigue.
To help patients manage, the Lymphoma Coalition has published a report on the impact of cancer-related fatigue and how to improve outcomes. Methods include greater awareness, regular screening, and interventions such as yoga or mindfulness-based cognitive therapy.
Are clinicians fine?
Nurses and physicians face challenges caring for patients with cancer.
Although “nurses love their jobs and are extremely committed,” the impact cancer has on a nursing career is often undervalued or “neglected,” said Lena Sharp, RN, PhD, of the Regional Cancer Centre, Stockholm-Gotland.
Burnout, in particular, remains a problem among oncologists and nurses, and it was made worse during the COVID-19 pandemic.
Fatima Cardoso, MD, explained that burnout has an impact on doctors as well as patients because it affects communication with patients and performance. Physicians can, for instance, appear detached, emotional, or tired.
Patients may then feel less inclined to tell their oncologist how they’re feeling, said Dr. Cardoso, director of the breast unit at Champalimaud Clinical Center, Lisbon.
It is important to remember to not just focus on the patient’s disease or treatment but to also ask how they are doing and what is going on in their lives.
Above all, “show that you care,” said Dr. Cardoso.
The Lymphoma Coalition Europe has relationships with Bristol-Myers Squibb, Establishment Labs, Kyowa Kirin, Novartis, Roche, Takeda. Dr. Cardoso has relationships with Amgen, Astellas/Medivation, AstraZeneca, Celgene, Daiichi Sankyo, Eisai, GE Oncology, Genentech, GlaxoSmithKline, and other companies. No other relevant financial relationships were reported.
A version of this article first appeared on Medscape.com.
PARIS – “I thought I was as exhausted, and isolated, and neglected as I could get, and then he came home.”
Those were the words of Kate Washington, PhD, from Sacramento as she gave a moving account of the immense burden she felt as caregiver to her husband with cancer.
She was taking part in the session, “I am FINE: Frustrated * Isolated * Neglected * Emotional,” at the annual meeting of the European Society for Medical Oncology. In that session,
Dr. Washington, author of “Already Toast: Caregiving and Burnout in America” (Boston: Beacon Press, 2021), explained that she cared for her husband and young family while he was “suffering through two different kinds of lymphoma and really devastating stem cell transplants.”
When her husband was first diagnosed with a rare form of lymphoma in 2015, he was placed on a watch-and-wait protocol. At that point, he seemed fine, Dr. Washington said.
A few months later, he started coughing up blood. After being rushed to the emergency department, doctors found that a slow-growing lung tumor had ruptured.
Three weeks later, he came out of the hospital with a collapsed lung – an effect of his chemotherapy, Dr. Washington said.
But that was hardly the last word. He soon experienced relapse with a “very aggressive” form of his disease, and in 2016, he underwent a stem cell transplant.
“He spent 1½ months in the hospital ... in isolation, not seeing our daughters,” Dr. Washington said. He lost his vision and developed grade 4 graft-versus-host disease, among other problems.
He was alive, just barely, Dr. Washington said.
“As you might imagine, I was pulled between the hospital and the home, taking care of our daughters, who were not seeing him during that time,” she recalled.
But every time someone asked her whether she was okay, she replied: “I am fine.”
“A total lie,” she admitted.
Dr. Washington felt frustrated, not only from the financial strain of out-of-pocket health care costs and lost earnings but also from fast evolving relationships and a feeling of being “unseen and underappreciated.”
Another jarring change: When her husband was discharged from the hospital, Dr. Washington was suddenly thrust into the role of full-time caretaker.
Her husband could not be left alone, his doctor had said. And with two young children, Dr. Washington did not know how she would manage.
The demands of being a full-time caregiver are intense. Caregivers, Dr. Washington explained, can spend 32 hours a week looking after a loved one with cancer.
Like Dr. Washington, most caregivers feel they have no choice but to take on this intense role – one for which they have little or no training or preparation. The nonstop demands leave little time for self-care and can lead to high rates of caregiver injury and illness.
Isolation often creeps in because it can be “hard to ask for help,” she said. About 30% of caregivers report having depression or anxiety, and 21% feel lonely.
“When he was very ill, I found it really difficult to connect with other people and my friends,” Dr. Washington recalled. “I didn’t feel like I could really adequately explain the kind of strain that I was under.”
Are patients fine?
Like caregivers, patients often say they are fine when they are not.
The toll cancer takes on patients is immense. Natacha Bolanos Fernandez, from the Lymphoma Coalition Europe, highlighted the physical, mental, and social strain that can affect patients with cancer.
The physical aspects can encompass a host of problems – fatigue, night sweats, weight loss, and the vomiting that accompanies many cancer treatments. Patients may face changes in their mobility and independence as well. The mental side of cancer can include anxiety, depression, and psychological distress, while the social aspects span changing, perhaps strained, relationships with family and friends.
Fatigue, in particular, is an underreported, underdiagnosed, and undertreated problem, Ms. Fernandez noted. According to recent survey data from the Lymphoma Coalition’s Global Patient Survey, 72% of patients reported fatigue. This problem worsened over time, with 59% reporting fatigue after their diagnosis and up to 82% among patients who experienced relapse two or more times.
Fatigue “may be getting worse rather than better over time,” Ms. Fernandez said, and many patients felt that their life had changed completely because of cancer-related fatigue.
To help patients manage, the Lymphoma Coalition has published a report on the impact of cancer-related fatigue and how to improve outcomes. Methods include greater awareness, regular screening, and interventions such as yoga or mindfulness-based cognitive therapy.
Are clinicians fine?
Nurses and physicians face challenges caring for patients with cancer.
Although “nurses love their jobs and are extremely committed,” the impact cancer has on a nursing career is often undervalued or “neglected,” said Lena Sharp, RN, PhD, of the Regional Cancer Centre, Stockholm-Gotland.
Burnout, in particular, remains a problem among oncologists and nurses, and it was made worse during the COVID-19 pandemic.
Fatima Cardoso, MD, explained that burnout has an impact on doctors as well as patients because it affects communication with patients and performance. Physicians can, for instance, appear detached, emotional, or tired.
Patients may then feel less inclined to tell their oncologist how they’re feeling, said Dr. Cardoso, director of the breast unit at Champalimaud Clinical Center, Lisbon.
It is important to remember to not just focus on the patient’s disease or treatment but to also ask how they are doing and what is going on in their lives.
Above all, “show that you care,” said Dr. Cardoso.
The Lymphoma Coalition Europe has relationships with Bristol-Myers Squibb, Establishment Labs, Kyowa Kirin, Novartis, Roche, Takeda. Dr. Cardoso has relationships with Amgen, Astellas/Medivation, AstraZeneca, Celgene, Daiichi Sankyo, Eisai, GE Oncology, Genentech, GlaxoSmithKline, and other companies. No other relevant financial relationships were reported.
A version of this article first appeared on Medscape.com.
AT ESMO CONGRESS 2022
Folic acid tied to a reduction in suicide attempts
new research suggests.
After adjusting for multiple factors, results from a large pharmaco-epidemiological study showed taking folic acid was associated with a 44% reduction in suicide events.
“These results are really putting folic acid squarely on the map as a potential for large-scale, population-level prevention,” lead author Robert D. Gibbons, PhD, professor of biostatistics, Center for Health Statistics, University of Chicago, said in an interview.
“Folic acid is safe, inexpensive, and generally available, and if future randomized controlled trials show this association is beyond a shadow of a doubt causal, we have a new tool in the arsenal,” Dr. Gibbons said.
Having such a tool would be extremely important given that suicide is such a significant public health crisis worldwide, he added.
The findings were published online in JAMA Psychiatry.
Previous research ‘fairly thin’
Folate, the naturally occurring form of B9, is essential for neurogenesis, nucleotide synthesis, and methylation of homocysteine. Past research has suggested that taking folate can prevent neural tube and heart defects in the fetus during pregnancy – and may prevent strokes and reduce age-related hearing loss in adults.
In psychiatry, the role of folate has been recognized for more than a decade. It may enhance the effects of antidepressants; and folate deficiency can predict poorer response to SSRIs.
This has led to recommendations for folate augmentation in patients with low or normal levels at the start of depression treatment.
Although previous research has shown a link between folic acid and suicidality, the findings have been “fairly thin,” with studies being “generally small, and many are case series,” Dr. Gibbons said.
The current study follows an earlier analysis that used a novel statistical methodology for generating drug safety signals that was developed by Dr. Gibbons and colleagues. That study compared rates of suicide attempts before and after initiation of 922 drugs with at least 3,000 prescriptions.
Its results showed 10 drugs were associated with increased risk after exposure, with the strongest associations for alprazolam, butalbital, hydrocodone, and combination codeine/promethazine. In addition, 44 drugs were associated with decreased risk, many of which were antidepressants and antipsychotics.
“One of the most interesting findings in terms of the decreased risk was for folic acid,” said Dr. Gibbons.
He and his colleagues initially thought this was because of women taking folic acid during pregnancy. But when restricting the analysis to men, they found the same effect.
Their next step was to carry out the current large-scale pharmaco-epidemiological study.
Prescriptions for pain
The researchers used a health claims database that included 164 million enrollees. The study cohort was comprised of 866,586 adults with private health insurance (81.3% women; 10.4% aged 60 years and older) who filled a folic acid prescription between 2012 and 2017.
More than half of the folic acid prescriptions were associated with pain disorders. About 48% were for a single agent at a dosage of 1 mg/d, which is the upper tolerable limit for adults – including in pregnancy and lactation.
Other single-agent daily dosages ranging from 0.4 mg to 5 mg accounted for 0.11% of prescriptions. The remainder were multivitamins.
The participants were followed for 24 months. The within-person analysis compared suicide attempts or self-harm events resulting in an outpatient visit or inpatient admission during periods of folic acid treatment versus during periods without treatment.
During the study period, the overall suicidal event rate was 133 per 100,000 population, which is one-fourth the national rate reported by the National Institutes of Health of 600 per 100,000.
After adjusting for age, sex, diagnoses related to suicidal behavior and folic acid deficiency, history of folate-reducing medications, and history of suicidal events, the estimated hazard ratio for suicide events when taking folic acid was 0.56 (95% confidence interal, 0.48-0.65) – which indicates a 44% reduction in suicide events.
“This is a very large decrease and is extremely significant and exciting,” Dr. Gibbons said.
He noted the decrease in suicidal events may have been even greater considering the study captured only prescription folic acid, and participants may also have also taken over-the-counter products.
“The 44% reduction in suicide attempts may actually be an underestimate,” said Dr. Gibbons.
Age and sex did not moderate the association between folic acid and suicide attempts, and a similar association was found in women of childbearing age.
Provocative results?
The investigators also assessed a negative control group of 236,610 individuals using cyanocobalamin during the study period. Cyanocobalamin is a form of vitamin B12 that is essential for metabolism, blood cell synthesis, and the nervous system. It does not contain folic acid and is commonly used to treat anemia.
Results showed no association between cyanocobalamin and suicidal events in the adjusted analysis (HR, 1.01; 95% CI, 0.80-1.27) or unadjusted analysis (HR, 1.02; 95% CI, 0.80-1.28).
Dr. Gibbons noted this result boosts the argument that the association between folic acid and reduced suicidal attempts “isn’t just about health-seeking behavior like taking vitamin supplements.”
Another sensitivity analysis showed every additional month of treatment was associated with a 5% reduction in the suicidal event rate.
“This means the longer you take folic acid, the greater the benefit, which is what you would expect to see if there was a real association between a treatment and an outcome,” said Dr. Gibbons.
The new results “are so provocative that they really mandate the need for a well-controlled randomized controlled trial of folic acid and suicide events,” possibly in a high-risk population such as veterans, he noted.
Such a study could use longitudinal assessments of suicidal events, such as the validated Computerized Adaptive Test Suicide Scale, he added. This continuous scale of suicidality ranges from subclinical, signifying helplessness, hopelessness, and loss of pleasure, to suicide attempts and completion.
As for study limitations, the investigators noted that this study was observational, so there could be selection effects. And using claims data likely underrepresented the number of suicidal events because of incomplete reporting. As the researchers pointed out, the rate of suicidal events in this study was much lower than the national rate.
Other limitations cited were that the association between folic acid and suicidal events may be explained by healthy user bias; and although the investigators conducted a sensitivity analysis in women of childbearing age, they did not have data on women actively planning for a pregnancy.
‘Impressive, encouraging’
In a comment, Shirley Yen, PhD, associate professor of psychology, Beth Israel Deaconess Medical Center and Harvard Medical School, both in Boston, described the new findings as “quite impressive” and “extremely encouraging.”
However, she noted “it’s too premature” to suggest widespread use of folic acid in patients with depressive symptoms.
Dr. Yen, who has researched suicide risks previously, was not involved with the current study.
She did agree with the investigators that the results call for “more robustly controlled studies. These could include double-blind, randomized, controlled trials that could “more formally assess” all folic acid usage as opposed to prescriptions only, Dr. Yen said.
The study was funded by the NIH, the Agency for Healthcare Research and Quality, and the Center of Excellence for Suicide Prevention. Dr. Gibbons reported serving as an expert witness in cases for the Department of Justice; receiving expert witness fees from Merck, GlaxoSmithKline, Pfizer, and Wyeth; and having founded Adaptive Testing Technologies, which distributes the Computerized Adaptive Test Suicide Scale. Dr. Yen reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
new research suggests.
After adjusting for multiple factors, results from a large pharmaco-epidemiological study showed taking folic acid was associated with a 44% reduction in suicide events.
“These results are really putting folic acid squarely on the map as a potential for large-scale, population-level prevention,” lead author Robert D. Gibbons, PhD, professor of biostatistics, Center for Health Statistics, University of Chicago, said in an interview.
“Folic acid is safe, inexpensive, and generally available, and if future randomized controlled trials show this association is beyond a shadow of a doubt causal, we have a new tool in the arsenal,” Dr. Gibbons said.
Having such a tool would be extremely important given that suicide is such a significant public health crisis worldwide, he added.
The findings were published online in JAMA Psychiatry.
Previous research ‘fairly thin’
Folate, the naturally occurring form of B9, is essential for neurogenesis, nucleotide synthesis, and methylation of homocysteine. Past research has suggested that taking folate can prevent neural tube and heart defects in the fetus during pregnancy – and may prevent strokes and reduce age-related hearing loss in adults.
In psychiatry, the role of folate has been recognized for more than a decade. It may enhance the effects of antidepressants; and folate deficiency can predict poorer response to SSRIs.
This has led to recommendations for folate augmentation in patients with low or normal levels at the start of depression treatment.
Although previous research has shown a link between folic acid and suicidality, the findings have been “fairly thin,” with studies being “generally small, and many are case series,” Dr. Gibbons said.
The current study follows an earlier analysis that used a novel statistical methodology for generating drug safety signals that was developed by Dr. Gibbons and colleagues. That study compared rates of suicide attempts before and after initiation of 922 drugs with at least 3,000 prescriptions.
Its results showed 10 drugs were associated with increased risk after exposure, with the strongest associations for alprazolam, butalbital, hydrocodone, and combination codeine/promethazine. In addition, 44 drugs were associated with decreased risk, many of which were antidepressants and antipsychotics.
“One of the most interesting findings in terms of the decreased risk was for folic acid,” said Dr. Gibbons.
He and his colleagues initially thought this was because of women taking folic acid during pregnancy. But when restricting the analysis to men, they found the same effect.
Their next step was to carry out the current large-scale pharmaco-epidemiological study.
Prescriptions for pain
The researchers used a health claims database that included 164 million enrollees. The study cohort was comprised of 866,586 adults with private health insurance (81.3% women; 10.4% aged 60 years and older) who filled a folic acid prescription between 2012 and 2017.
More than half of the folic acid prescriptions were associated with pain disorders. About 48% were for a single agent at a dosage of 1 mg/d, which is the upper tolerable limit for adults – including in pregnancy and lactation.
Other single-agent daily dosages ranging from 0.4 mg to 5 mg accounted for 0.11% of prescriptions. The remainder were multivitamins.
The participants were followed for 24 months. The within-person analysis compared suicide attempts or self-harm events resulting in an outpatient visit or inpatient admission during periods of folic acid treatment versus during periods without treatment.
During the study period, the overall suicidal event rate was 133 per 100,000 population, which is one-fourth the national rate reported by the National Institutes of Health of 600 per 100,000.
After adjusting for age, sex, diagnoses related to suicidal behavior and folic acid deficiency, history of folate-reducing medications, and history of suicidal events, the estimated hazard ratio for suicide events when taking folic acid was 0.56 (95% confidence interal, 0.48-0.65) – which indicates a 44% reduction in suicide events.
“This is a very large decrease and is extremely significant and exciting,” Dr. Gibbons said.
He noted the decrease in suicidal events may have been even greater considering the study captured only prescription folic acid, and participants may also have also taken over-the-counter products.
“The 44% reduction in suicide attempts may actually be an underestimate,” said Dr. Gibbons.
Age and sex did not moderate the association between folic acid and suicide attempts, and a similar association was found in women of childbearing age.
Provocative results?
The investigators also assessed a negative control group of 236,610 individuals using cyanocobalamin during the study period. Cyanocobalamin is a form of vitamin B12 that is essential for metabolism, blood cell synthesis, and the nervous system. It does not contain folic acid and is commonly used to treat anemia.
Results showed no association between cyanocobalamin and suicidal events in the adjusted analysis (HR, 1.01; 95% CI, 0.80-1.27) or unadjusted analysis (HR, 1.02; 95% CI, 0.80-1.28).
Dr. Gibbons noted this result boosts the argument that the association between folic acid and reduced suicidal attempts “isn’t just about health-seeking behavior like taking vitamin supplements.”
Another sensitivity analysis showed every additional month of treatment was associated with a 5% reduction in the suicidal event rate.
“This means the longer you take folic acid, the greater the benefit, which is what you would expect to see if there was a real association between a treatment and an outcome,” said Dr. Gibbons.
The new results “are so provocative that they really mandate the need for a well-controlled randomized controlled trial of folic acid and suicide events,” possibly in a high-risk population such as veterans, he noted.
Such a study could use longitudinal assessments of suicidal events, such as the validated Computerized Adaptive Test Suicide Scale, he added. This continuous scale of suicidality ranges from subclinical, signifying helplessness, hopelessness, and loss of pleasure, to suicide attempts and completion.
As for study limitations, the investigators noted that this study was observational, so there could be selection effects. And using claims data likely underrepresented the number of suicidal events because of incomplete reporting. As the researchers pointed out, the rate of suicidal events in this study was much lower than the national rate.
Other limitations cited were that the association between folic acid and suicidal events may be explained by healthy user bias; and although the investigators conducted a sensitivity analysis in women of childbearing age, they did not have data on women actively planning for a pregnancy.
‘Impressive, encouraging’
In a comment, Shirley Yen, PhD, associate professor of psychology, Beth Israel Deaconess Medical Center and Harvard Medical School, both in Boston, described the new findings as “quite impressive” and “extremely encouraging.”
However, she noted “it’s too premature” to suggest widespread use of folic acid in patients with depressive symptoms.
Dr. Yen, who has researched suicide risks previously, was not involved with the current study.
She did agree with the investigators that the results call for “more robustly controlled studies. These could include double-blind, randomized, controlled trials that could “more formally assess” all folic acid usage as opposed to prescriptions only, Dr. Yen said.
The study was funded by the NIH, the Agency for Healthcare Research and Quality, and the Center of Excellence for Suicide Prevention. Dr. Gibbons reported serving as an expert witness in cases for the Department of Justice; receiving expert witness fees from Merck, GlaxoSmithKline, Pfizer, and Wyeth; and having founded Adaptive Testing Technologies, which distributes the Computerized Adaptive Test Suicide Scale. Dr. Yen reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
new research suggests.
After adjusting for multiple factors, results from a large pharmaco-epidemiological study showed taking folic acid was associated with a 44% reduction in suicide events.
“These results are really putting folic acid squarely on the map as a potential for large-scale, population-level prevention,” lead author Robert D. Gibbons, PhD, professor of biostatistics, Center for Health Statistics, University of Chicago, said in an interview.
“Folic acid is safe, inexpensive, and generally available, and if future randomized controlled trials show this association is beyond a shadow of a doubt causal, we have a new tool in the arsenal,” Dr. Gibbons said.
Having such a tool would be extremely important given that suicide is such a significant public health crisis worldwide, he added.
The findings were published online in JAMA Psychiatry.
Previous research ‘fairly thin’
Folate, the naturally occurring form of B9, is essential for neurogenesis, nucleotide synthesis, and methylation of homocysteine. Past research has suggested that taking folate can prevent neural tube and heart defects in the fetus during pregnancy – and may prevent strokes and reduce age-related hearing loss in adults.
In psychiatry, the role of folate has been recognized for more than a decade. It may enhance the effects of antidepressants; and folate deficiency can predict poorer response to SSRIs.
This has led to recommendations for folate augmentation in patients with low or normal levels at the start of depression treatment.
Although previous research has shown a link between folic acid and suicidality, the findings have been “fairly thin,” with studies being “generally small, and many are case series,” Dr. Gibbons said.
The current study follows an earlier analysis that used a novel statistical methodology for generating drug safety signals that was developed by Dr. Gibbons and colleagues. That study compared rates of suicide attempts before and after initiation of 922 drugs with at least 3,000 prescriptions.
Its results showed 10 drugs were associated with increased risk after exposure, with the strongest associations for alprazolam, butalbital, hydrocodone, and combination codeine/promethazine. In addition, 44 drugs were associated with decreased risk, many of which were antidepressants and antipsychotics.
“One of the most interesting findings in terms of the decreased risk was for folic acid,” said Dr. Gibbons.
He and his colleagues initially thought this was because of women taking folic acid during pregnancy. But when restricting the analysis to men, they found the same effect.
Their next step was to carry out the current large-scale pharmaco-epidemiological study.
Prescriptions for pain
The researchers used a health claims database that included 164 million enrollees. The study cohort was comprised of 866,586 adults with private health insurance (81.3% women; 10.4% aged 60 years and older) who filled a folic acid prescription between 2012 and 2017.
More than half of the folic acid prescriptions were associated with pain disorders. About 48% were for a single agent at a dosage of 1 mg/d, which is the upper tolerable limit for adults – including in pregnancy and lactation.
Other single-agent daily dosages ranging from 0.4 mg to 5 mg accounted for 0.11% of prescriptions. The remainder were multivitamins.
The participants were followed for 24 months. The within-person analysis compared suicide attempts or self-harm events resulting in an outpatient visit or inpatient admission during periods of folic acid treatment versus during periods without treatment.
During the study period, the overall suicidal event rate was 133 per 100,000 population, which is one-fourth the national rate reported by the National Institutes of Health of 600 per 100,000.
After adjusting for age, sex, diagnoses related to suicidal behavior and folic acid deficiency, history of folate-reducing medications, and history of suicidal events, the estimated hazard ratio for suicide events when taking folic acid was 0.56 (95% confidence interal, 0.48-0.65) – which indicates a 44% reduction in suicide events.
“This is a very large decrease and is extremely significant and exciting,” Dr. Gibbons said.
He noted the decrease in suicidal events may have been even greater considering the study captured only prescription folic acid, and participants may also have also taken over-the-counter products.
“The 44% reduction in suicide attempts may actually be an underestimate,” said Dr. Gibbons.
Age and sex did not moderate the association between folic acid and suicide attempts, and a similar association was found in women of childbearing age.
Provocative results?
The investigators also assessed a negative control group of 236,610 individuals using cyanocobalamin during the study period. Cyanocobalamin is a form of vitamin B12 that is essential for metabolism, blood cell synthesis, and the nervous system. It does not contain folic acid and is commonly used to treat anemia.
Results showed no association between cyanocobalamin and suicidal events in the adjusted analysis (HR, 1.01; 95% CI, 0.80-1.27) or unadjusted analysis (HR, 1.02; 95% CI, 0.80-1.28).
Dr. Gibbons noted this result boosts the argument that the association between folic acid and reduced suicidal attempts “isn’t just about health-seeking behavior like taking vitamin supplements.”
Another sensitivity analysis showed every additional month of treatment was associated with a 5% reduction in the suicidal event rate.
“This means the longer you take folic acid, the greater the benefit, which is what you would expect to see if there was a real association between a treatment and an outcome,” said Dr. Gibbons.
The new results “are so provocative that they really mandate the need for a well-controlled randomized controlled trial of folic acid and suicide events,” possibly in a high-risk population such as veterans, he noted.
Such a study could use longitudinal assessments of suicidal events, such as the validated Computerized Adaptive Test Suicide Scale, he added. This continuous scale of suicidality ranges from subclinical, signifying helplessness, hopelessness, and loss of pleasure, to suicide attempts and completion.
As for study limitations, the investigators noted that this study was observational, so there could be selection effects. And using claims data likely underrepresented the number of suicidal events because of incomplete reporting. As the researchers pointed out, the rate of suicidal events in this study was much lower than the national rate.
Other limitations cited were that the association between folic acid and suicidal events may be explained by healthy user bias; and although the investigators conducted a sensitivity analysis in women of childbearing age, they did not have data on women actively planning for a pregnancy.
‘Impressive, encouraging’
In a comment, Shirley Yen, PhD, associate professor of psychology, Beth Israel Deaconess Medical Center and Harvard Medical School, both in Boston, described the new findings as “quite impressive” and “extremely encouraging.”
However, she noted “it’s too premature” to suggest widespread use of folic acid in patients with depressive symptoms.
Dr. Yen, who has researched suicide risks previously, was not involved with the current study.
She did agree with the investigators that the results call for “more robustly controlled studies. These could include double-blind, randomized, controlled trials that could “more formally assess” all folic acid usage as opposed to prescriptions only, Dr. Yen said.
The study was funded by the NIH, the Agency for Healthcare Research and Quality, and the Center of Excellence for Suicide Prevention. Dr. Gibbons reported serving as an expert witness in cases for the Department of Justice; receiving expert witness fees from Merck, GlaxoSmithKline, Pfizer, and Wyeth; and having founded Adaptive Testing Technologies, which distributes the Computerized Adaptive Test Suicide Scale. Dr. Yen reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
FROM JAMA PSYCHIATRY
Physician bias may prevent quality care for patients with disabilities
For Tara Lagu, MD, the realization that the health care system was broken for patients with disabilities came when a woman she had been treating seemed to keep ignoring Dr. Lagu’s request to see a urologist.
When Dr. Lagu asked the patient’s two attentive daughters about the delay, their response surprised her. The women said they couldn’t find a urologist who was willing to see a patient in a wheelchair.
Surprised and a bit doubtful, Dr. Lagu checked around. She found that, indeed, the only way to get her patient in to see the type of physician required was to send her by ambulance.
“It opened my eyes to how hard it is for patients with disabilities to navigate the health care system,” Dr. Lagu said.
Dr. Lagu, director of the Center for Health Services and Outcomes Research at Northwestern University in Chicago, decided to take a closer look at how her colleagues in medicine care for – or not, as the case proved – the roughly one in four American adults, and millions of children, with disabilities.
In a series of three focus groups, Dr. Lagu and colleagues identified a range of obstacles – including some physician attitudes – that prevent people with disabilities from getting adequate care.
For the study, published in Health Affairs, the researchers interviewed 22 physicians in three groups: Nonrural primary care physicians, rural primary care physicians, and specialists in rheumatology, neurology, obstetrics/gynecology, orthopedics, and ophthalmology.
During the interviews, conducted in the fall of 2018, participants were asked about providing care for five specific types of disabilities: mobility, hearing, vision, mental health, and intellectual limitations.
Lack of experience, logistics often cited
Some physicians admitted that limited resources and training left them without the space and necessary knowledge to properly care for patients with disabilities. They felt they lacked the expertise or exposure to care for individuals with disabilities, nor did they have enough time and space to properly accommodate these patients, according to the researchers. Some said they struggled to coordinate care for individuals with disabilities and did not know which types of accessible equipment, such as adjustable tables and chair scales, were needed or how to use them.
Several physicians also noted that they are inadequately reimbursed for the special accommodations – including additional staff, equipment, and time – required to care for these patients. One primary care physician said he hired a sign-language interpreter for a patient but the bill for the services exceeded the amount insurance reimbursed. As a result, he said, he spent $30 of his own money per visit to see the patient.
Because of these limitations, some physicians in the focus groups said they try to turn away patients with disabilities. Both specialists and general practitioners said they had told patients with disabilities that they didn’t feel they could provide the care needed, and suggested they look elsewhere. A few were surprisingly – even upsettingly – honest, Dr. Lagu said, making statements such as: “I am not the doctor for you.”
‘We really need a rewrite’
Previous work has shown that people with disabilities have worse health outcomes, such as undetected cancer, obesity, and cardiovascular disease.
But “the disability itself isn’t what leads to worse outcomes,” said Allison Kessler, MD, section chief of the Renée Crown Center for Spinal Cord Innovation and associate director of the Shirley Ryan AbilityLab in Chicago*. This study does a good job at highlighting “the need for change on multiple levels,” said Dr. Kessler, who was not a member of the study team.
“People with disabilities have all these disparities in access and outcomes. We’ve never understood why. I think the why is complicated,” Dr. Lagu added. “I think this study suggests some of the negative outcomes are due to explicit bias.”
“It’s also clear that the current framework of health care in the United States does not lend to allowing physicians and medical providers the time needed to adequately address patient issues – those with disabilities or just multiple complex problems,” Colin O’Reilly, DO, vice president and chief medical officer at Children’s Specialized Hospital, an acute rehabilitation facility affiliated with RWJBarnabas Health, in New Brunswick, N.J. “We really need a rewrite.”
However, Dr. O’Reilly said, such a small study population with no control group and no mention of physician resources makes it difficult to come to a strong conclusion about physician bias and discriminatory attitudes against individuals with disabilities.
Dr. Lagu agreed, saying this research “is not conclusive in any way.” The excuses doctors use to discharge patients with disabilities, such as “we don’t accept your insurance,” “we aren’t taking new patients,” and “we can’t provide you with the appropriate care,” could be legitimate, the study authors wrote. But the “disparities in care for people with disabilities suggest that there is a pattern of more frequently denying care to them than people without a disability,” they added.
Dr. Kessler said many of her patients have told her they experience barriers to care. Some say finding an office with the necessary equipment is a challenge or that they often don’t feel welcome.
The Americans With Disabilities Act (ADA) is a federal civil rights law that prohibits discrimination against individuals with disabilities in all public and private places that are open to the general public, including medical offices.
“It is difficult to enforce the ADA in medical settings,” the researchers noted. “Explanations physicians gave in this study could, for any single case of denying care, be legitimate.” Knowing whether a particular instance of denial of care represents discrimination related to disability is “nearly impossible,” they wrote.
All the experts agreed that the study adds valuable insight into an ongoing health disparity. And while system and policy changes are required, Dr. Kessler said, individual physicians can take steps to improve the situation.
A physician in an academic setting can look at the curriculum and the medical school and see about increasing exposure to patients with disabilities earlier in training. In a practice, physicians can retrain staff to ask every patient if an accommodation is needed. “Each one of those changes can only help us move our system in the right direction,” Dr. Kessler said.
The study was supported by a grant from the Eunice Kennedy Shriver National Institute of Child Health and Human Development.
*Correction, 10/5/22: This article includes a corrected title for Dr. Allison Kessler.
A version of this article first appeared on Medscape.com.
For Tara Lagu, MD, the realization that the health care system was broken for patients with disabilities came when a woman she had been treating seemed to keep ignoring Dr. Lagu’s request to see a urologist.
When Dr. Lagu asked the patient’s two attentive daughters about the delay, their response surprised her. The women said they couldn’t find a urologist who was willing to see a patient in a wheelchair.
Surprised and a bit doubtful, Dr. Lagu checked around. She found that, indeed, the only way to get her patient in to see the type of physician required was to send her by ambulance.
“It opened my eyes to how hard it is for patients with disabilities to navigate the health care system,” Dr. Lagu said.
Dr. Lagu, director of the Center for Health Services and Outcomes Research at Northwestern University in Chicago, decided to take a closer look at how her colleagues in medicine care for – or not, as the case proved – the roughly one in four American adults, and millions of children, with disabilities.
In a series of three focus groups, Dr. Lagu and colleagues identified a range of obstacles – including some physician attitudes – that prevent people with disabilities from getting adequate care.
For the study, published in Health Affairs, the researchers interviewed 22 physicians in three groups: Nonrural primary care physicians, rural primary care physicians, and specialists in rheumatology, neurology, obstetrics/gynecology, orthopedics, and ophthalmology.
During the interviews, conducted in the fall of 2018, participants were asked about providing care for five specific types of disabilities: mobility, hearing, vision, mental health, and intellectual limitations.
Lack of experience, logistics often cited
Some physicians admitted that limited resources and training left them without the space and necessary knowledge to properly care for patients with disabilities. They felt they lacked the expertise or exposure to care for individuals with disabilities, nor did they have enough time and space to properly accommodate these patients, according to the researchers. Some said they struggled to coordinate care for individuals with disabilities and did not know which types of accessible equipment, such as adjustable tables and chair scales, were needed or how to use them.
Several physicians also noted that they are inadequately reimbursed for the special accommodations – including additional staff, equipment, and time – required to care for these patients. One primary care physician said he hired a sign-language interpreter for a patient but the bill for the services exceeded the amount insurance reimbursed. As a result, he said, he spent $30 of his own money per visit to see the patient.
Because of these limitations, some physicians in the focus groups said they try to turn away patients with disabilities. Both specialists and general practitioners said they had told patients with disabilities that they didn’t feel they could provide the care needed, and suggested they look elsewhere. A few were surprisingly – even upsettingly – honest, Dr. Lagu said, making statements such as: “I am not the doctor for you.”
‘We really need a rewrite’
Previous work has shown that people with disabilities have worse health outcomes, such as undetected cancer, obesity, and cardiovascular disease.
But “the disability itself isn’t what leads to worse outcomes,” said Allison Kessler, MD, section chief of the Renée Crown Center for Spinal Cord Innovation and associate director of the Shirley Ryan AbilityLab in Chicago*. This study does a good job at highlighting “the need for change on multiple levels,” said Dr. Kessler, who was not a member of the study team.
“People with disabilities have all these disparities in access and outcomes. We’ve never understood why. I think the why is complicated,” Dr. Lagu added. “I think this study suggests some of the negative outcomes are due to explicit bias.”
“It’s also clear that the current framework of health care in the United States does not lend to allowing physicians and medical providers the time needed to adequately address patient issues – those with disabilities or just multiple complex problems,” Colin O’Reilly, DO, vice president and chief medical officer at Children’s Specialized Hospital, an acute rehabilitation facility affiliated with RWJBarnabas Health, in New Brunswick, N.J. “We really need a rewrite.”
However, Dr. O’Reilly said, such a small study population with no control group and no mention of physician resources makes it difficult to come to a strong conclusion about physician bias and discriminatory attitudes against individuals with disabilities.
Dr. Lagu agreed, saying this research “is not conclusive in any way.” The excuses doctors use to discharge patients with disabilities, such as “we don’t accept your insurance,” “we aren’t taking new patients,” and “we can’t provide you with the appropriate care,” could be legitimate, the study authors wrote. But the “disparities in care for people with disabilities suggest that there is a pattern of more frequently denying care to them than people without a disability,” they added.
Dr. Kessler said many of her patients have told her they experience barriers to care. Some say finding an office with the necessary equipment is a challenge or that they often don’t feel welcome.
The Americans With Disabilities Act (ADA) is a federal civil rights law that prohibits discrimination against individuals with disabilities in all public and private places that are open to the general public, including medical offices.
“It is difficult to enforce the ADA in medical settings,” the researchers noted. “Explanations physicians gave in this study could, for any single case of denying care, be legitimate.” Knowing whether a particular instance of denial of care represents discrimination related to disability is “nearly impossible,” they wrote.
All the experts agreed that the study adds valuable insight into an ongoing health disparity. And while system and policy changes are required, Dr. Kessler said, individual physicians can take steps to improve the situation.
A physician in an academic setting can look at the curriculum and the medical school and see about increasing exposure to patients with disabilities earlier in training. In a practice, physicians can retrain staff to ask every patient if an accommodation is needed. “Each one of those changes can only help us move our system in the right direction,” Dr. Kessler said.
The study was supported by a grant from the Eunice Kennedy Shriver National Institute of Child Health and Human Development.
*Correction, 10/5/22: This article includes a corrected title for Dr. Allison Kessler.
A version of this article first appeared on Medscape.com.
For Tara Lagu, MD, the realization that the health care system was broken for patients with disabilities came when a woman she had been treating seemed to keep ignoring Dr. Lagu’s request to see a urologist.
When Dr. Lagu asked the patient’s two attentive daughters about the delay, their response surprised her. The women said they couldn’t find a urologist who was willing to see a patient in a wheelchair.
Surprised and a bit doubtful, Dr. Lagu checked around. She found that, indeed, the only way to get her patient in to see the type of physician required was to send her by ambulance.
“It opened my eyes to how hard it is for patients with disabilities to navigate the health care system,” Dr. Lagu said.
Dr. Lagu, director of the Center for Health Services and Outcomes Research at Northwestern University in Chicago, decided to take a closer look at how her colleagues in medicine care for – or not, as the case proved – the roughly one in four American adults, and millions of children, with disabilities.
In a series of three focus groups, Dr. Lagu and colleagues identified a range of obstacles – including some physician attitudes – that prevent people with disabilities from getting adequate care.
For the study, published in Health Affairs, the researchers interviewed 22 physicians in three groups: Nonrural primary care physicians, rural primary care physicians, and specialists in rheumatology, neurology, obstetrics/gynecology, orthopedics, and ophthalmology.
During the interviews, conducted in the fall of 2018, participants were asked about providing care for five specific types of disabilities: mobility, hearing, vision, mental health, and intellectual limitations.
Lack of experience, logistics often cited
Some physicians admitted that limited resources and training left them without the space and necessary knowledge to properly care for patients with disabilities. They felt they lacked the expertise or exposure to care for individuals with disabilities, nor did they have enough time and space to properly accommodate these patients, according to the researchers. Some said they struggled to coordinate care for individuals with disabilities and did not know which types of accessible equipment, such as adjustable tables and chair scales, were needed or how to use them.
Several physicians also noted that they are inadequately reimbursed for the special accommodations – including additional staff, equipment, and time – required to care for these patients. One primary care physician said he hired a sign-language interpreter for a patient but the bill for the services exceeded the amount insurance reimbursed. As a result, he said, he spent $30 of his own money per visit to see the patient.
Because of these limitations, some physicians in the focus groups said they try to turn away patients with disabilities. Both specialists and general practitioners said they had told patients with disabilities that they didn’t feel they could provide the care needed, and suggested they look elsewhere. A few were surprisingly – even upsettingly – honest, Dr. Lagu said, making statements such as: “I am not the doctor for you.”
‘We really need a rewrite’
Previous work has shown that people with disabilities have worse health outcomes, such as undetected cancer, obesity, and cardiovascular disease.
But “the disability itself isn’t what leads to worse outcomes,” said Allison Kessler, MD, section chief of the Renée Crown Center for Spinal Cord Innovation and associate director of the Shirley Ryan AbilityLab in Chicago*. This study does a good job at highlighting “the need for change on multiple levels,” said Dr. Kessler, who was not a member of the study team.
“People with disabilities have all these disparities in access and outcomes. We’ve never understood why. I think the why is complicated,” Dr. Lagu added. “I think this study suggests some of the negative outcomes are due to explicit bias.”
“It’s also clear that the current framework of health care in the United States does not lend to allowing physicians and medical providers the time needed to adequately address patient issues – those with disabilities or just multiple complex problems,” Colin O’Reilly, DO, vice president and chief medical officer at Children’s Specialized Hospital, an acute rehabilitation facility affiliated with RWJBarnabas Health, in New Brunswick, N.J. “We really need a rewrite.”
However, Dr. O’Reilly said, such a small study population with no control group and no mention of physician resources makes it difficult to come to a strong conclusion about physician bias and discriminatory attitudes against individuals with disabilities.
Dr. Lagu agreed, saying this research “is not conclusive in any way.” The excuses doctors use to discharge patients with disabilities, such as “we don’t accept your insurance,” “we aren’t taking new patients,” and “we can’t provide you with the appropriate care,” could be legitimate, the study authors wrote. But the “disparities in care for people with disabilities suggest that there is a pattern of more frequently denying care to them than people without a disability,” they added.
Dr. Kessler said many of her patients have told her they experience barriers to care. Some say finding an office with the necessary equipment is a challenge or that they often don’t feel welcome.
The Americans With Disabilities Act (ADA) is a federal civil rights law that prohibits discrimination against individuals with disabilities in all public and private places that are open to the general public, including medical offices.
“It is difficult to enforce the ADA in medical settings,” the researchers noted. “Explanations physicians gave in this study could, for any single case of denying care, be legitimate.” Knowing whether a particular instance of denial of care represents discrimination related to disability is “nearly impossible,” they wrote.
All the experts agreed that the study adds valuable insight into an ongoing health disparity. And while system and policy changes are required, Dr. Kessler said, individual physicians can take steps to improve the situation.
A physician in an academic setting can look at the curriculum and the medical school and see about increasing exposure to patients with disabilities earlier in training. In a practice, physicians can retrain staff to ask every patient if an accommodation is needed. “Each one of those changes can only help us move our system in the right direction,” Dr. Kessler said.
The study was supported by a grant from the Eunice Kennedy Shriver National Institute of Child Health and Human Development.
*Correction, 10/5/22: This article includes a corrected title for Dr. Allison Kessler.
A version of this article first appeared on Medscape.com.
The hunt for N-acetylcysteine: Medicine or dietary supplement?
Medicine or dietary supplement? N-acetylcysteine (NAC) is marketed as both and in 2021, the supplement abruptly became difficult to find, causing distress to people who had been using it for a variety of conditions. The story behind its disappearance is one of a cat-and-mouse chase between manufacturers, advocacy agencies, and the Food and Drug Administration.
NAC is a medication that was approved by the FDA in 1963. It has two FDA-approved uses: To prevent hepatotoxicity after overdose with acetaminophen, administered intravenously or by mouth, and as a mucolytic agent – previously available as Mucomyst, now available only as a generic – given by inhaler or nebulizer for pulmonary illnesses. Since the 1990s, NAC has been labeled by manufacturers as a dietary supplement. It is a derivative of the amino acid L-cysteine and a precursor to glutathione, an antioxidant.
Studies have had small sample sizes, and the supplement has not been considered an “off label” use of an already available medication. People have purchased NAC from retail drug and big box stores, Amazon, and online companies. So what’s the problem?
In July 2020, the FDA issued a warning letter to Purple Biosciences LLC, because of claims on the company’s website that the product “Purple Tree,” sold by Amazon, could cure hangovers that result from alcohol intoxication. The letter discussed justification for why a hangover is a disease, and goes on to note:
Based on the product label on your website, it appears that you intend to market your Purple Tree® product, which contains N-acetyl-L-cysteine (NAC), as a dietary supplement. However, even if your product labeling did not have therapeutic claims that make your product an unapproved new drug, your product could not be a dietary supplement, because it does not meet the definition of dietary supplement ... products containing that article are outside the definition of a dietary supplement, unless before such approval that article was marketed as a dietary supplement or as a food. NAC was approved as a new drug under section 505 of the Act [21 U.S.C. § 355] on September 14, 1963.
The issue here is that because NAC was first approved as a drug in 1963, it cannot be marketed as a supplement. If it had been marketed as a supplement before it was approved as a drug by the FDA, then it could remain on the market. The fact that it had been sold as a supplement since the 1990s and could be classified as an “old dietary ingredient” according to the Dietary Supplement Health and Education Act of 1994 did not seem to matter. Following the warning letter, NAC was pulled from shelves and websites.
Citizen petitions allow people and organizations to request that the FDA change their policy. During summer 2021, there were two citizen petitions – one from the Council for Responsible Nutrition (CRN) and another from the Natural Products Association (NPA) – asking that the FDA look at policy around NAC. In response, in November 2021, the FDA put out a request for more information about how long NAC had been used and if there were safety concerns, to determine if making it a lawful supplement would be appropriate. CRN promptly released a response that they were “extremely dissatisfied” and felt this was an unnecessary tactic to delay a decision. Two members of Congress wrote letters to the FDA in support of leaving NAC as an available supplement. Congressman Jeff Duncan noted that there were over 1,170 products containing NAC.
The FDA continued to issue responses. On March 31, 2022, the agency formally denied the requests of the two citizen petitions, and 3 weeks later the Guidance for Industry: Policy Regarding N-acetyl-L-cysteine was released, saying that the FDA would “... exercise enforcement discretion with respect to the sale and distribution of certain products that contain NAC.” While NAC was still not considered a supplement, no safety issues had been identified to date. Thus, while the FDA investigation continues, the agency will essentially look the other way.
The agency will consider rulemaking to include NAC as a supplement, a process that may take years. In a notice of final guidance released in August 2022, the FDA reiterated, “unless we identify safety-related concerns during our ongoing review, FDA intends to exercise enforcement discretion until either of the following occurs: we complete notice-and-comment rulemaking to allow the use of NAC in or as a dietary supplement (should we move forward with such proceedings) or we deny the NPA citizen petition’s request for rulemaking.”
It’s a win for the consumer who wants the supplement, and a half-win for the supplement manufacturers and their advocacy organizations who would like NAC to be an official dietary supplement. But just to be clear, the issue is one of a technicality: If NAC had been marketed as a supplement before it was a drug, it would just be a dietary supplement without all the controversy and scrutiny. It was not pulled because of a clinical concern.
For now, NAC is again readily available.
Dr. Miller is a coauthor of “Committed: The Battle Over Involuntary Psychiatric Care” (Johns Hopkins University Press, 2016). She has a private practice and is assistant professor of psychiatry and behavioral sciences at Johns Hopkins University, Baltimore. She has disclosed no relevant financial relationships.
Medicine or dietary supplement? N-acetylcysteine (NAC) is marketed as both and in 2021, the supplement abruptly became difficult to find, causing distress to people who had been using it for a variety of conditions. The story behind its disappearance is one of a cat-and-mouse chase between manufacturers, advocacy agencies, and the Food and Drug Administration.
NAC is a medication that was approved by the FDA in 1963. It has two FDA-approved uses: To prevent hepatotoxicity after overdose with acetaminophen, administered intravenously or by mouth, and as a mucolytic agent – previously available as Mucomyst, now available only as a generic – given by inhaler or nebulizer for pulmonary illnesses. Since the 1990s, NAC has been labeled by manufacturers as a dietary supplement. It is a derivative of the amino acid L-cysteine and a precursor to glutathione, an antioxidant.
Studies have had small sample sizes, and the supplement has not been considered an “off label” use of an already available medication. People have purchased NAC from retail drug and big box stores, Amazon, and online companies. So what’s the problem?
In July 2020, the FDA issued a warning letter to Purple Biosciences LLC, because of claims on the company’s website that the product “Purple Tree,” sold by Amazon, could cure hangovers that result from alcohol intoxication. The letter discussed justification for why a hangover is a disease, and goes on to note:
Based on the product label on your website, it appears that you intend to market your Purple Tree® product, which contains N-acetyl-L-cysteine (NAC), as a dietary supplement. However, even if your product labeling did not have therapeutic claims that make your product an unapproved new drug, your product could not be a dietary supplement, because it does not meet the definition of dietary supplement ... products containing that article are outside the definition of a dietary supplement, unless before such approval that article was marketed as a dietary supplement or as a food. NAC was approved as a new drug under section 505 of the Act [21 U.S.C. § 355] on September 14, 1963.
The issue here is that because NAC was first approved as a drug in 1963, it cannot be marketed as a supplement. If it had been marketed as a supplement before it was approved as a drug by the FDA, then it could remain on the market. The fact that it had been sold as a supplement since the 1990s and could be classified as an “old dietary ingredient” according to the Dietary Supplement Health and Education Act of 1994 did not seem to matter. Following the warning letter, NAC was pulled from shelves and websites.
Citizen petitions allow people and organizations to request that the FDA change their policy. During summer 2021, there were two citizen petitions – one from the Council for Responsible Nutrition (CRN) and another from the Natural Products Association (NPA) – asking that the FDA look at policy around NAC. In response, in November 2021, the FDA put out a request for more information about how long NAC had been used and if there were safety concerns, to determine if making it a lawful supplement would be appropriate. CRN promptly released a response that they were “extremely dissatisfied” and felt this was an unnecessary tactic to delay a decision. Two members of Congress wrote letters to the FDA in support of leaving NAC as an available supplement. Congressman Jeff Duncan noted that there were over 1,170 products containing NAC.
The FDA continued to issue responses. On March 31, 2022, the agency formally denied the requests of the two citizen petitions, and 3 weeks later the Guidance for Industry: Policy Regarding N-acetyl-L-cysteine was released, saying that the FDA would “... exercise enforcement discretion with respect to the sale and distribution of certain products that contain NAC.” While NAC was still not considered a supplement, no safety issues had been identified to date. Thus, while the FDA investigation continues, the agency will essentially look the other way.
The agency will consider rulemaking to include NAC as a supplement, a process that may take years. In a notice of final guidance released in August 2022, the FDA reiterated, “unless we identify safety-related concerns during our ongoing review, FDA intends to exercise enforcement discretion until either of the following occurs: we complete notice-and-comment rulemaking to allow the use of NAC in or as a dietary supplement (should we move forward with such proceedings) or we deny the NPA citizen petition’s request for rulemaking.”
It’s a win for the consumer who wants the supplement, and a half-win for the supplement manufacturers and their advocacy organizations who would like NAC to be an official dietary supplement. But just to be clear, the issue is one of a technicality: If NAC had been marketed as a supplement before it was a drug, it would just be a dietary supplement without all the controversy and scrutiny. It was not pulled because of a clinical concern.
For now, NAC is again readily available.
Dr. Miller is a coauthor of “Committed: The Battle Over Involuntary Psychiatric Care” (Johns Hopkins University Press, 2016). She has a private practice and is assistant professor of psychiatry and behavioral sciences at Johns Hopkins University, Baltimore. She has disclosed no relevant financial relationships.
Medicine or dietary supplement? N-acetylcysteine (NAC) is marketed as both and in 2021, the supplement abruptly became difficult to find, causing distress to people who had been using it for a variety of conditions. The story behind its disappearance is one of a cat-and-mouse chase between manufacturers, advocacy agencies, and the Food and Drug Administration.
NAC is a medication that was approved by the FDA in 1963. It has two FDA-approved uses: To prevent hepatotoxicity after overdose with acetaminophen, administered intravenously or by mouth, and as a mucolytic agent – previously available as Mucomyst, now available only as a generic – given by inhaler or nebulizer for pulmonary illnesses. Since the 1990s, NAC has been labeled by manufacturers as a dietary supplement. It is a derivative of the amino acid L-cysteine and a precursor to glutathione, an antioxidant.
Studies have had small sample sizes, and the supplement has not been considered an “off label” use of an already available medication. People have purchased NAC from retail drug and big box stores, Amazon, and online companies. So what’s the problem?
In July 2020, the FDA issued a warning letter to Purple Biosciences LLC, because of claims on the company’s website that the product “Purple Tree,” sold by Amazon, could cure hangovers that result from alcohol intoxication. The letter discussed justification for why a hangover is a disease, and goes on to note:
Based on the product label on your website, it appears that you intend to market your Purple Tree® product, which contains N-acetyl-L-cysteine (NAC), as a dietary supplement. However, even if your product labeling did not have therapeutic claims that make your product an unapproved new drug, your product could not be a dietary supplement, because it does not meet the definition of dietary supplement ... products containing that article are outside the definition of a dietary supplement, unless before such approval that article was marketed as a dietary supplement or as a food. NAC was approved as a new drug under section 505 of the Act [21 U.S.C. § 355] on September 14, 1963.
The issue here is that because NAC was first approved as a drug in 1963, it cannot be marketed as a supplement. If it had been marketed as a supplement before it was approved as a drug by the FDA, then it could remain on the market. The fact that it had been sold as a supplement since the 1990s and could be classified as an “old dietary ingredient” according to the Dietary Supplement Health and Education Act of 1994 did not seem to matter. Following the warning letter, NAC was pulled from shelves and websites.
Citizen petitions allow people and organizations to request that the FDA change their policy. During summer 2021, there were two citizen petitions – one from the Council for Responsible Nutrition (CRN) and another from the Natural Products Association (NPA) – asking that the FDA look at policy around NAC. In response, in November 2021, the FDA put out a request for more information about how long NAC had been used and if there were safety concerns, to determine if making it a lawful supplement would be appropriate. CRN promptly released a response that they were “extremely dissatisfied” and felt this was an unnecessary tactic to delay a decision. Two members of Congress wrote letters to the FDA in support of leaving NAC as an available supplement. Congressman Jeff Duncan noted that there were over 1,170 products containing NAC.
The FDA continued to issue responses. On March 31, 2022, the agency formally denied the requests of the two citizen petitions, and 3 weeks later the Guidance for Industry: Policy Regarding N-acetyl-L-cysteine was released, saying that the FDA would “... exercise enforcement discretion with respect to the sale and distribution of certain products that contain NAC.” While NAC was still not considered a supplement, no safety issues had been identified to date. Thus, while the FDA investigation continues, the agency will essentially look the other way.
The agency will consider rulemaking to include NAC as a supplement, a process that may take years. In a notice of final guidance released in August 2022, the FDA reiterated, “unless we identify safety-related concerns during our ongoing review, FDA intends to exercise enforcement discretion until either of the following occurs: we complete notice-and-comment rulemaking to allow the use of NAC in or as a dietary supplement (should we move forward with such proceedings) or we deny the NPA citizen petition’s request for rulemaking.”
It’s a win for the consumer who wants the supplement, and a half-win for the supplement manufacturers and their advocacy organizations who would like NAC to be an official dietary supplement. But just to be clear, the issue is one of a technicality: If NAC had been marketed as a supplement before it was a drug, it would just be a dietary supplement without all the controversy and scrutiny. It was not pulled because of a clinical concern.
For now, NAC is again readily available.
Dr. Miller is a coauthor of “Committed: The Battle Over Involuntary Psychiatric Care” (Johns Hopkins University Press, 2016). She has a private practice and is assistant professor of psychiatry and behavioral sciences at Johns Hopkins University, Baltimore. She has disclosed no relevant financial relationships.
Deep brain stimulation effective for OCD, but barriers persist
“DBS is a viable option for treatment-resistant OCD that can be expected to produce significant clinical benefit in about two out of three cases,” study investigator Wayne Goodman, MD, chair, department of psychiatry and behavioral sciences, Baylor College of Medicine, Houston, said in a statement.
However, “challenges in access still prevent many eligible individuals from getting this life-improving therapy,” co-investigator Sameer Sheth, MD, PhD, vice chair of research, department of neurosurgery at Baylor, told this news organization.
The study was published online in the Journal of Neurology, Neurosurgery and Psychiatry.
50% reduction in symptoms
The analysis included 34 studies conducted from 2005 to 2021, including 9 randomized controlled trials (RCTs) and 25 non-RCTs, involving 352 patients with treatment-resistant OCD.
Both RCTs and non-RCTs had a predominantly low risk of bias.
The results show an average 14.3-point, or 47%, reduction (P < .01) in Yale-Brown Obsessive-Compulsive Scale scores with DBS at last follow-up, with no significant difference between RCTs and non-RCTs.
Two-thirds (66%) of patients fully responded to the DBS at last follow-up, the authors found.
DBS for treatment-resistant OCD also had a “strong” effect on comorbid depression, with 47% of patients considered “full responders” relative to their preoperative (baseline) depression status and an additional 16% considered partial responders (with a 30%-49% reduction in pre/post-treatment depressive symptoms).
“The demonstrated effects of DBS in this report are even more impressive when one considers that these patients have failed numerous behavioral and pharmacological therapies,” said study investigator Eric Storch, PhD, professor and vice chair for the department of psychiatry and behavioral sciences at Baylor.
The rate of hardware-related complications was roughly 8% and infection rate was about 4% – in line with other data.
This study “offers hope for patients with severe symptoms of OCD whose disorder did not respond to a range of conventional therapies,” Dr. Goodman said.
The bigger story
Dr. Sheth said the challenges in getting appropriate OCD patients access to DBS are multifactorial.
“Psychiatrists and general practitioners and even patients are not aware of it, and insurance company policies are often out of date and ignorant of recent data such as those in this study,” Dr. Sheth explained.
“Hopefully, improved awareness in the future will reverse these trends and lead to increased access for patients in need of this therapy,” Dr. Sheth said.
Access to DBS for OCD is clearly the “bigger story” here, Brian Kopell, MD, who was not involved in the study, told this news organization.
This meta-analysis “confirms what all of us that do this with some regularity know – that DBS for OCD can be extremely helpful in patients who are refractory to standard OCD therapies,” said Dr. Kopell, department of neurosurgery and director, Center for Neuromodulation, Mount Sinai Health System, New York.
Yet, there is a dramatic difference in getting reimbursement for DBS in a case of dystonia vs. OCD.
In the United States, DBS has humanitarian device exemption for use in both dystonia and OCD, Dr. Kopell noted.
“Yet because dystonia is a movement disorder, I can get DBS for dystonia paid for by most private insurance – no big deal,” Dr. Kopell said.
“But OCD, because it’s deemed a psychiatric disorder, is treated like the redheaded stepchild and it’s monumentally hard to get insurance to pay for it – and if you can’t pay for it, you can’t do it. Simple as that,” he added.
The study was supported by the McNair Foundation and the Dana Foundation. Dr. Storch is a consultant for Biohaven and owns stock in nView. Dr. Sheth is a consultant for Boston Scientific, NeuroPace, Abbott, and Zimmer Biomet. Dr. Kopell reports no relevant financial relationships.
A version of this article first appeared on Medscape.com.
“DBS is a viable option for treatment-resistant OCD that can be expected to produce significant clinical benefit in about two out of three cases,” study investigator Wayne Goodman, MD, chair, department of psychiatry and behavioral sciences, Baylor College of Medicine, Houston, said in a statement.
However, “challenges in access still prevent many eligible individuals from getting this life-improving therapy,” co-investigator Sameer Sheth, MD, PhD, vice chair of research, department of neurosurgery at Baylor, told this news organization.
The study was published online in the Journal of Neurology, Neurosurgery and Psychiatry.
50% reduction in symptoms
The analysis included 34 studies conducted from 2005 to 2021, including 9 randomized controlled trials (RCTs) and 25 non-RCTs, involving 352 patients with treatment-resistant OCD.
Both RCTs and non-RCTs had a predominantly low risk of bias.
The results show an average 14.3-point, or 47%, reduction (P < .01) in Yale-Brown Obsessive-Compulsive Scale scores with DBS at last follow-up, with no significant difference between RCTs and non-RCTs.
Two-thirds (66%) of patients fully responded to the DBS at last follow-up, the authors found.
DBS for treatment-resistant OCD also had a “strong” effect on comorbid depression, with 47% of patients considered “full responders” relative to their preoperative (baseline) depression status and an additional 16% considered partial responders (with a 30%-49% reduction in pre/post-treatment depressive symptoms).
“The demonstrated effects of DBS in this report are even more impressive when one considers that these patients have failed numerous behavioral and pharmacological therapies,” said study investigator Eric Storch, PhD, professor and vice chair for the department of psychiatry and behavioral sciences at Baylor.
The rate of hardware-related complications was roughly 8% and infection rate was about 4% – in line with other data.
This study “offers hope for patients with severe symptoms of OCD whose disorder did not respond to a range of conventional therapies,” Dr. Goodman said.
The bigger story
Dr. Sheth said the challenges in getting appropriate OCD patients access to DBS are multifactorial.
“Psychiatrists and general practitioners and even patients are not aware of it, and insurance company policies are often out of date and ignorant of recent data such as those in this study,” Dr. Sheth explained.
“Hopefully, improved awareness in the future will reverse these trends and lead to increased access for patients in need of this therapy,” Dr. Sheth said.
Access to DBS for OCD is clearly the “bigger story” here, Brian Kopell, MD, who was not involved in the study, told this news organization.
This meta-analysis “confirms what all of us that do this with some regularity know – that DBS for OCD can be extremely helpful in patients who are refractory to standard OCD therapies,” said Dr. Kopell, department of neurosurgery and director, Center for Neuromodulation, Mount Sinai Health System, New York.
Yet, there is a dramatic difference in getting reimbursement for DBS in a case of dystonia vs. OCD.
In the United States, DBS has humanitarian device exemption for use in both dystonia and OCD, Dr. Kopell noted.
“Yet because dystonia is a movement disorder, I can get DBS for dystonia paid for by most private insurance – no big deal,” Dr. Kopell said.
“But OCD, because it’s deemed a psychiatric disorder, is treated like the redheaded stepchild and it’s monumentally hard to get insurance to pay for it – and if you can’t pay for it, you can’t do it. Simple as that,” he added.
The study was supported by the McNair Foundation and the Dana Foundation. Dr. Storch is a consultant for Biohaven and owns stock in nView. Dr. Sheth is a consultant for Boston Scientific, NeuroPace, Abbott, and Zimmer Biomet. Dr. Kopell reports no relevant financial relationships.
A version of this article first appeared on Medscape.com.
“DBS is a viable option for treatment-resistant OCD that can be expected to produce significant clinical benefit in about two out of three cases,” study investigator Wayne Goodman, MD, chair, department of psychiatry and behavioral sciences, Baylor College of Medicine, Houston, said in a statement.
However, “challenges in access still prevent many eligible individuals from getting this life-improving therapy,” co-investigator Sameer Sheth, MD, PhD, vice chair of research, department of neurosurgery at Baylor, told this news organization.
The study was published online in the Journal of Neurology, Neurosurgery and Psychiatry.
50% reduction in symptoms
The analysis included 34 studies conducted from 2005 to 2021, including 9 randomized controlled trials (RCTs) and 25 non-RCTs, involving 352 patients with treatment-resistant OCD.
Both RCTs and non-RCTs had a predominantly low risk of bias.
The results show an average 14.3-point, or 47%, reduction (P < .01) in Yale-Brown Obsessive-Compulsive Scale scores with DBS at last follow-up, with no significant difference between RCTs and non-RCTs.
Two-thirds (66%) of patients fully responded to the DBS at last follow-up, the authors found.
DBS for treatment-resistant OCD also had a “strong” effect on comorbid depression, with 47% of patients considered “full responders” relative to their preoperative (baseline) depression status and an additional 16% considered partial responders (with a 30%-49% reduction in pre/post-treatment depressive symptoms).
“The demonstrated effects of DBS in this report are even more impressive when one considers that these patients have failed numerous behavioral and pharmacological therapies,” said study investigator Eric Storch, PhD, professor and vice chair for the department of psychiatry and behavioral sciences at Baylor.
The rate of hardware-related complications was roughly 8% and infection rate was about 4% – in line with other data.
This study “offers hope for patients with severe symptoms of OCD whose disorder did not respond to a range of conventional therapies,” Dr. Goodman said.
The bigger story
Dr. Sheth said the challenges in getting appropriate OCD patients access to DBS are multifactorial.
“Psychiatrists and general practitioners and even patients are not aware of it, and insurance company policies are often out of date and ignorant of recent data such as those in this study,” Dr. Sheth explained.
“Hopefully, improved awareness in the future will reverse these trends and lead to increased access for patients in need of this therapy,” Dr. Sheth said.
Access to DBS for OCD is clearly the “bigger story” here, Brian Kopell, MD, who was not involved in the study, told this news organization.
This meta-analysis “confirms what all of us that do this with some regularity know – that DBS for OCD can be extremely helpful in patients who are refractory to standard OCD therapies,” said Dr. Kopell, department of neurosurgery and director, Center for Neuromodulation, Mount Sinai Health System, New York.
Yet, there is a dramatic difference in getting reimbursement for DBS in a case of dystonia vs. OCD.
In the United States, DBS has humanitarian device exemption for use in both dystonia and OCD, Dr. Kopell noted.
“Yet because dystonia is a movement disorder, I can get DBS for dystonia paid for by most private insurance – no big deal,” Dr. Kopell said.
“But OCD, because it’s deemed a psychiatric disorder, is treated like the redheaded stepchild and it’s monumentally hard to get insurance to pay for it – and if you can’t pay for it, you can’t do it. Simple as that,” he added.
The study was supported by the McNair Foundation and the Dana Foundation. Dr. Storch is a consultant for Biohaven and owns stock in nView. Dr. Sheth is a consultant for Boston Scientific, NeuroPace, Abbott, and Zimmer Biomet. Dr. Kopell reports no relevant financial relationships.
A version of this article first appeared on Medscape.com.
FROM JOURNAL OF NEUROLOGY, NEUROSURGERY AND PSYCHIATRY